{ "id": "AIBD-0265", "title": "An implanted interface restored communication at home for nearly seven years", "summary": "A woman with locked-in ALS used the Utrecht NeuroProsthesis to communicate at home for nearly seven years.", "date_observed": "2016-11-12", "date_basis": "source publication", "date_precision": "day", "benefit_status": "reported", "source_collection": null, "source_entry": null, "account": "A woman with locked-in ALS received the Utrecht NeuroProsthesis in October 2015. After training, she selected letters and called a caregiver by attempting to move her hand. Caregivers set up the equipment, but she then used it without research staff. It became her only technological means of communication after she lost reliable eye tracking. Home use continued for nearly seven years and ended in March 2023 as control became unreliable. Researchers considered ALS-related brain changes the likely explanation, without proving a single cause. The documented decoder combined brain-signal features and fitted thresholds rather than a named machine-learning model.", "category": "benefit created", "unexpected": false, "purpose": "Provide autonomous communication for a person with late-stage ALS who could no longer rely on eye tracking", "system": "Utrecht NeuroProsthesis with Medtronic Activa PC+S and Tobii Communicator 5", "model_version": null, "developer": "University Medical Center Utrecht (Brain Center; Ramsey and Vansteensel)", "deployer": "University Medical Center Utrecht; home use by the participant", "location": "Utrecht, Netherlands", "domain": "Health; assistive communication", "segment": "People with locked-in syndrome from ALS", "benefit_type": "Improved Accessibility", "taxonomy_note": null, "registry_ids": { "clinicaltrials_gov": "NCT02224469" }, "ratings": [ { "group": "personal", "depth": 3, "reason": "The participant regained a lasting ability to communicate at home. The reports do not establish prevention of a separate serious harm." } ], "ai_role": { "status": "assessed", "statement": "The documented decoder combines normalized brain-signal features and fitted thresholds to generate clicks. Whether that mechanism qualifies as AI remains unresolved. The communication benefit itself is documented." }, "evidence": [ { "kind": "peer-reviewed study", "citation": "Vansteensel MJ, Pels EGM, Bleichner MG, et al. N Engl J Med 375:2060-2066 (2016)", "title": "Fully Implanted Brain-Computer Interface in a Locked-In Patient with ALS", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5326682/", "date": "2016-11-12", "written_by": "makers", "quote": "the patient accurately and independently controlled a computer typing program 28 weeks after electrode placement, at the equivalent of two letters per minute." }, { "kind": "peer-reviewed study", "citation": "Vansteensel MJ, Leinders S, Branco MP, et al. N Engl J Med 391:619-626 (2024)", "title": "Longevity of a Brain-Computer Interface for Amyotrophic Lateral Sclerosis", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11395392/", "date": "2024-08-14", "written_by": "makers", "quote": null }, { "kind": "report", "citation": "Sacha Leinders, Fully Implanted Brain-Computer Interface Technology for People with Locked-In Syndrome: Bringing it Home: Results from the Pioneering Utrecht NeuroProsthesis Clinical Trial (PhD diss., Utrecht University, 2025), 35, 137–157, doi:10.33540/2877. Chapter 6 reproduces the 2024 report and its supplementary material.", "title": "Fully Implanted Brain-Computer Interface Technology for People with Locked-In Syndrome: Bringing it Home", "url": "https://doi.org/10.33540/2877", "date": "2025-05-14", "written_by": "makers", "quote": null } ], "replication": { "produced_by": [ "Subdural electrodes over motor cortex with an implanted transmitter", "Band-power features from attempted hand movement converted into click commands", "Months of algorithm refinement to suppress unintended clicks" ], "must_hold": [ "Neural signal amplitude remains sufficient (it declined with ALS-related atrophy after about six years)", "The participant can attempt hand movement reliably" ], "echoes": [ { "date": "2024-08-14", "setting": "Same participant followed for nearly seven years, not an independent replication", "model_version": null, "outcome": "recurred", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11395392/" }, { "date": "2024-10-22", "setting": "Johns Hopkins click-based ECoG BCI with an LSTM detector, laboratory use only", "model_version": "LSTM click detector", "outcome": "recurred", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11494178/" } ] }, "paired_incident": null, "headline": "An implanted interface restored communication for nearly seven years", "metric": "seven years of independent at-home use", "comparator": null, "later": { "status": "reversed", "date": null, "note": "Home use ended in March 2023 when control became unreliable. The source reports the month, not an exact day.", "quote": null, "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11395392/" }, "value": null, "developer_country": "Netherlands", "deployer_country": "Netherlands", "unrated_because": null, "brief_notes": null, "brief": null, "revisions": [ { "date": "2026-10-20", "change": "Record drafted from the cited sources.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Country of the developer and the deployer added from the organization's own site or a registry.", "source": "https://en.wikipedia.org/wiki/University_Medical_Center_Utrecht; https://en.wikipedia.org/wiki/University_Medical_Center_Utrecht", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Prose pass: a rating reason, account, the system's part rewritten in shorter sentences with abbreviations expanded; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-21", "change": "Notes about which sources could be read were reworded for readers; facts, figures and quotations unchanged.", "source": null, "editor": "AIBD" }, { "date": "2026-10-25", "change": "Reviewed the original evidence and supporting material; updated system details, methods, outcomes, limitations, costs, and source lineage.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5326682/", "editor": "AIBD" } ], "confidence": "claimed", "shade": "low", "claim_status": "The makers' claim", "claim_basis": "Sources: two peer-reviewed studies from the makers and the makers' report. The cited evidence includes no independent source and no finding by a regulator or court.", "profile": { "case_id": "AIBD-0265", "catalog_version": "1.0.0", "source_fingerprint": "6e096fc354b9df3d5e40dfd7d2a1b7b394116ab3c791c6e5ea0f51631824ac1c", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" }, { "collection_id": "querist", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002", "AIBD-0265-source-0003" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "NCT02224469" ], "role": "evaluations" }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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The documented decoder combines signal features and individually fitted thresholds.", "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Whether this interface uses AI remains unresolved. The documented decoder combines signal features and individually fitted thresholds." } }, "assessments[].alternatives": { "state": "value_present", "value": { "kind": "text", "text": "Depth 4 would require a separately established serious harm averted. The technical AI boundary remains distinct from the depth of the documented benefit." }, "provenance": { "kind": "curatorial", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Depth 4 would require a separately established serious harm averted. The technical AI boundary remains distinct from the depth of the documented benefit." } }, "assessments[].assessor_date": { "state": "value_present", "value": { "kind": "structured", "data": { "assessor": "AIBD, AI-assisted source review", "date": "2026-10-25" } }, "provenance": { "kind": "curatorial", "basis": "Review of the sources listed in the lineage assessment.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD, 25 October 2026." } }, "assessments[].depth": { "state": "value_present", "value": { "kind": "structured", "data": { "ratings": [ { "group": "personal", "depth": 3, "reason": "The participant regained a lasting ability to communicate at home. The reports do not establish prevention of a separate serious harm." } ] } }, "provenance": { "kind": "curatorial", "basis": "Local five-level depth rubric; Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Depth 3 for restored communication that lasted nearly seven years." } }, "assessments[].display_confidence": { "state": "value_present", "value": { "kind": "text", "text": "Peer-reviewed reports by the developers about one participant. The outline is retained." }, "provenance": { "kind": "curatorial", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Peer-reviewed reports by the developers about one participant. The outline is retained." } }, "assessments[].rationale": { "state": "value_present", "value": { "kind": "text", "text": "Depth 3 for restored communication that lasted nearly seven years." }, "provenance": { "kind": "curatorial", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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Evidence strength is assessed separately." }, "provenance": { "kind": "curatorial", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The depth describes the reported result. Evidence strength is assessed separately." } }, "assessments[].target": { "state": "value_present", "value": { "kind": "text", "text": "The benefit described here, for the beneficiary groups shown." }, "provenance": { "kind": "curatorial", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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Replacement-device availability became a concern during follow-up." } }, "brief": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial" }, "case_kind": { "state": "value_present", "value": { "kind": "text", "text": "A single-participant clinical study with long-term follow-up." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A single-participant clinical study with long-term follow-up." } }, "case_links[]": { "state": "value_present", "value": { "kind": "text", "text": "AIBD-0052 cites this interface as a historical comparison. The two systems were not tested head to head." }, "provenance": { "kind": "curatorial", "basis": "Oxley et al. (2020), Discussion.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD-0052 cites this interface as a historical comparison. The two systems were not tested head to head." } }, "claims[].evidence_links": { "state": "value_present", "value": { "kind": "structured", "data": { "initial_communication": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5326682/", "locator": "Results" }, "duration_and_end": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11395392/", "locator": "Results: At-Home Use" }, "decoder_and_safety": { "url": "https://dspace.library.uu.nl/bitstream/handle/1874/457163/boekieuubieb_-_67f2a3c93d7ff.pdf?isAllowed=y&sequence=1", "locator": "p. 35; Chapter 6 supplement, pp. 152–156" } } }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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Implant components were used off label." }, "provenance": { "kind": "source_review", "basis": "2016 Methods; 2024 Methods; NCT02224469, protocol UMCU 12-370.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The study received ethics approval and informed consent. Implant components were used off label." } }, "decisions[].institution_task": { "state": "value_present", "value": { "kind": "text", "text": "UMC Utrecht tested an implanted means of communication for people with severe paralysis." }, "provenance": { "kind": "source_review", "basis": "2016 Methods; 2024 Methods; NCT02224469, protocol UMCU 12-370.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "UMC Utrecht tested an implanted means of communication for people with severe paralysis." } }, "decisions[].success_criterion": { "state": "value_present", "value": { "kind": "text", "text": "Researchers evaluated communication control, usability, and long-term stability. The case report did not define a single financial or clinical pass threshold." }, "provenance": { "kind": "source_review", "basis": "2016 Methods; 2024 Methods; NCT02224469, protocol UMCU 12-370.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Researchers evaluated communication control, usability, and long-term stability. The case report did not define a single financial or clinical pass threshold." } }, "deployment_stage": { "state": "value_present", "value": { "kind": "text", "text": "An investigational implant used at home after months of training." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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(2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].costs[]": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "Medtronic provided the implant, antenna, and receiver to UMC Utrecht free of charge. Their market value and the full costs of care were not reported.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "Medtronic provided the implant, antenna, and receiver to UMC Utrecht free of charge. Their market value and the full costs of care were not reported." } }, "economics[].counterfactual": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].currency_price_basis": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].gross_net": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].measure_type": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].period_unit": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].realization": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].recipient_payer": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].return_payback": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "economics[].valuation_method": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The reviewed sources do not report a monetary valuation or financial return.", "review_state": "reviewed", "coverage": "complete", "family": "monetary observations", "display": { "answer": "The reviewed sources do not report a monetary valuation or financial return." } }, "evaluations[].ai_uplift": { "state": "value_present", "value": { "kind": "text", "text": "The study demonstrates the whole implanted interface. It does not isolate a machine-learning contribution, and its decoder is described through signal processing and fitted thresholds." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The study demonstrates the whole implanted interface. It does not isolate a machine-learning contribution, and its decoder is described through signal processing and fitted thresholds." } }, "evaluations[].comparator": { "state": "value_present", "value": { "kind": "text", "text": "There was no control group. The participant also used an eye tracker until eye movement became unreliable." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "There was no control group. The participant also used an eye tracker until eye movement became unreliable." } }, "evaluations[].design": { "state": "value_present", "value": { "kind": "text", "text": "A prospective single-participant study, followed by a longitudinal report on the same woman." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A prospective single-participant study, followed by a longitudinal report on the same woman." } }, "evaluations[].effect": { "state": "value_present", "value": { "kind": "structured", "data": { "target_accuracy_mean_percent": 91, "target_accuracy_SD": 6, "click_accuracy_mean_percent": 87, "click_accuracy_SD": 7, "spelling_accuracy_mean_percent": 89, "spelling_accuracy_SD": 6, "seconds_per_letter_with_prediction": 33, "seconds_per_letter_without_prediction": 52, "initial_home_use_days": 32, "initial_average_minutes_per_use_day": 86, "long_term_home_use": "nearly seven years" } }, "provenance": { "kind": "source_review", "basis": "2016 Results: Communication and Independent Home Use; 2024 Results.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Initial spelling accuracy averaged 89%. With word prediction, she selected about two letters per minute. Home use continued for nearly seven years." } }, "evaluations[].exposure": { "state": "value_present", "value": { "kind": "text", "text": "The initial report describes 67 two-hour research sessions over 262 days. Home use without investigators began on day 197 after implantation." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The initial report describes 67 two-hour research sessions over 262 days. Home use without investigators began on day 197 after implantation." } }, "evaluations[].id": { "state": "value_present", "value": { "kind": "text", "text": "NCT02224469" }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "NCT02224469" } }, "evaluations[].measurement_method": { "state": "value_present", "value": { "kind": "text", "text": "Researchers tested clicks and spelling, collected satisfaction ratings, logged when the home system was available, and monitored brain signals and imaging." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Researchers tested clicks and spelling, collected satisfaction ratings, logged when the home system was available, and monitored brain signals and imaging." } }, "evaluations[].metric": { "state": "value_present", "value": { "kind": "text", "text": "Selection accuracy, spelling speed, time with the system available at home, satisfaction, and persistence of usable control." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Selection accuracy, spelling speed, time with the system available at home, satisfaction, and persistence of usable control." } }, "evaluations[].reproduction_materials": { "state": "value_present", "value": { "kind": "text", "text": "The original paper links two example task runs in Dryad. The follow-up supplement describes signal analysis. The thesis documents click thresholds and reproduces the follow-up supplement." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The original paper links two example task runs in Dryad. The follow-up supplement describes signal analysis. The thesis documents click thresholds and reproduces the follow-up supplement." } }, "evaluations[].setting_sample": { "state": "value_present", "value": { "kind": "text", "text": "One participant at UMC Utrecht and in her home. Repeated task runs are observations from that same person." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "One participant at UMC Utrecht and in her home. Repeated task runs are observations from that same person." } }, "evaluations[].uncertainty_limitations": { "state": "value_present", "value": { "kind": "text", "text": "The result concerns one person. Home logs show availability, not continuous active communication. Declining control coincided with ALS progression, without proving a single cause." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The result concerns one person. Home logs show availability, not continuous active communication. Declining control coincided with ALS progression, without proving a single cause." } }, "external_references[]": { "state": "value_present", "value": { "kind": "structured", "data": { "ClinicalTrials.gov": "NCT02224469" } }, "provenance": { "kind": "source_review", "basis": "Original study registration, inspected through the ClinicalTrials.gov API.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "NCT02224469" } }, "follow_up[]": { "state": "value_present", "value": { "kind": "text", "text": "The system became her only communication technology after eye tracking ended in 2019. Night use stopped in October 2022, and all home use ended in March 2023." }, "provenance": { "kind": "source_review", "basis": "2024 Results: At-Home Use.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The system became her only communication technology after eye tracking ended in 2019. Night use stopped in October 2022, and all home use ended in March 2023." } }, "human_oversight": { "state": "value_present", "value": { "kind": "text", "text": "Clinicians implanted and monitored the device. Researchers adjusted decoding settings, and caregivers helped set up and maintain the home equipment." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Clinicians implanted and monitored the device. Researchers adjusted decoding settings, and caregivers helped set up and maintain the home equipment." } }, "id": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "id": "AIBD-0265" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "id" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "infrastructure_dependencies[]": { "state": "value_present", "value": { "kind": "text", "text": "The system required implanted electrodes, a chest transmitter, an external antenna and receiver, a tablet, communication software, and continuing caregiver support." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The system required implanted electrodes, a chest transmitter, an external antenna and receiver, a tablet, communication software, and continuing caregiver support." } }, "outcomes[].beneficiaries": { "state": "value_present", "value": { "kind": "text", "text": "One woman with advanced ALS who was 58 when she entered the study." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "One woman with advanced ALS who was 58 when she entered the study." } }, "outcomes[].beneficiary_count": { "state": "value_present", "value": { "kind": "structured", "data": { "unique_participants": 1, "initial_research_sessions": 67, "target_runs": 83, "click_runs": 37, "spelling_runs": 44, "counting_note": "Repeated measurements and two reports concern the same participant." } }, "provenance": { "kind": "source_review", "basis": "2016 Results; 2024 Methods.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "One participant, followed repeatedly. The two papers do not describe two separate beneficiaries." } }, "outcomes[].benefit_type": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "benefit_type": "Improved Accessibility" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "benefit_type" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "outcomes[].claim": { "state": "value_present", "value": { "kind": "text", "text": "The participant could communicate and call a caregiver at home after training." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The participant could communicate and call a caregiver at home after training." } }, "outcomes[].distribution": { "state": "value_present", "value": { "kind": "text", "text": "This was one participant with suitable motor signals and caregiver support. The study does not establish the same result for all people with locked-in ALS." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "This was one participant with suitable motor signals and caregiver support. The study does not establish the same result for all people with locked-in ALS." } }, "outcomes[].duration": { "state": "value_present", "value": { "kind": "text", "text": "Independent home use lasted nearly seven years and ended in March 2023." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Independent home use lasted nearly seven years and ended in March 2023." } }, "outcomes[].id": { "state": "value_present", "value": { "kind": "text", "text": "AIBD-0265-outcome-01" }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD-0265-outcome-01" } }, "outcomes[].stakeholder_group": { "state": "value_present", "value": { "kind": "structured", "data": { "groups": [ "personal" ] } }, "provenance": { "kind": "curatorial", "basis": "The beneficiary groups correspond to the reviewed depth assessments.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "People." } }, "outcomes[].status": { "state": "value_present", "value": { "kind": "text", "text": "Observed in one participant over several years." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Observed in one participant over several years." } }, "outcomes[].tradeoffs": { "state": "value_present", "value": { "kind": "text", "text": "The participant underwent two operations and extensive training. The follow-up supplement records a procedure-related fever with hospital readmission. Later loss of reliable control ended home use." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The participant underwent two operations and extensive training. The follow-up supplement records a procedure-related fever with hospital readmission. Later loss of reliable control ended home use." } }, "outcomes[].unexpected": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "unexpected": false, "purpose": "Provide autonomous communication for a person with late-stage ALS who could no longer rely on eye tracking" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "unexpected", "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "places[]": { "state": "value_present", "value": { "kind": "text", "text": "Implantation, follow-up, and home use took place in the Netherlands." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Implantation, follow-up, and home use took place in the Netherlands." } }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "Provide autonomous communication for a person with late-stage ALS who could no longer rely on eye tracking" } }, "provenance": { "kind": "legacy_record", "basis": "Preserved from the existing AIBD record; external sources were not rechecked.", "record_fields": [ "purpose" ], "source_refs": [] }, "review_state": "record_mapped", "coverage": "partial" }, "record_dates": { "state": "value_present", "value": { "kind": "structured", "data": { "implantation": "2015-10-27", "transmitter_connection": "2015-10-30", "initial_publication": "2016-11-12", "home_use_end": { "year": 2023, "month": 3, "precision": "month" }, "follow_up_publication": "2024-08-14" } }, "provenance": { "kind": "source_review", "basis": "2016 Methods; 2024 Results and publisher history.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Implantation began on 27 October 2015. Home use ended in March 2023. The follow-up report appeared on 14 August 2024." } }, "replication.attempts[]": { "state": "value_present", "value": { "kind": "structured", "data": { "same_participant_follow_up": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11395392/", "publication": "2024-08-14", "independent_replication": false }, "other_legacy_comparison": "The Johns Hopkins comparison already in this record was not reopened in this review." } }, "provenance": { "kind": "source_review", "basis": "2024 Methods. The separate Johns Hopkins comparison remains outside this review.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "partial", "display": { "answer": "The 2024 report follows the same woman, rather than a second user of this device." } }, "replication.conditions": { "state": "value_present", "value": { "kind": "text", "text": "Preserved motor signals, adequate cognition, caregiver support, individual training, and access to replacement equipment were necessary." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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Later thesis details are identified as such.", "relationship": "Supplement to the initial paper.", "source_refs": [ "AIBD-0265-source-0001" ] }, { "url": "https://clinicaltrials.gov/study/NCT02224469", "locator": "Identification, status, study design, and sponsor.", "contribution": "Actual trial and ethics identifiers.", "relationship": "Investigator-supplied registration.", "source_refs": [ "AIBD-0265-source-0001" ] } ], "excluded_or_consolidated_sources": [ { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC5326682/", "reason": "Second quotation from the same 2016 article consolidated." }, { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11395392/", "reason": "Second quotation from the same 2024 article consolidated." } ], "review_scope": "Methods, results, counts, chronology, AI identity and operation, human responsibilities, limitations, and economic evidence." } }, "provenance": { "kind": "source_review", "basis": "The original materials and exact locators are listed in this assessment.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002", "AIBD-0265-source-0003" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The original studies and their supporting materials are linked to the findings that they support." } }, "strategic_assessments[]": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "family": "strategic assessments" }, "summary": { "state": "value_present", "value": { "kind": "text", "text": "A woman with locked-in ALS used the Utrecht NeuroProsthesis to communicate at home for nearly seven years." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A woman with locked-in ALS used the Utrecht NeuroProsthesis to communicate at home for nearly seven years." } }, "systems[].autonomy_permissions": { "state": "value_present", "value": { "kind": "text", "text": "The participant chose when to generate a click. The software scanned letters and converted her selections into text or a caregiver call." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The participant chose when to generate a click. The software scanned letters and converted her selections into text or a caregiver call." } }, "systems[].component_role": { "state": "value_present", "value": { "kind": "text", "text": "The implant recorded brain activity. A decoder converted attempted movements into clicks for spelling and calling a caregiver." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The implant recorded brain activity. A decoder converted attempted movements into clicks for spelling and calling a caregiver." } }, "systems[].deployment_configuration": { "state": "value_present", "value": { "kind": "structured", "data": { "implant": "Medtronic Resume II electrode strips and Activa PC+S", "application": "Tobii Communicator 5", "initial_tablet": "Microsoft Surface Pro 4", "decoder": "z-scored low-frequency power subtracted from z-scored high-frequency power, followed by a threshold and click-window rules", "at_home_signal_frequency_Hz": 5, "low_frequency_band_Hz": [ 10, 30 ], "high_frequency_band_Hz": [ 65, 95 ], "December_2021_change": "Low-frequency activity from E2–E3 combined with high-frequency activity from E10–E12.", "exact_original_threshold": "Not recovered from the original 2016 supplement." } }, "provenance": { "kind": "source_review", "basis": "2016 Methods: Communication and Home Use; 2024 Methods; thesis, p. 35 and pp. 152–155.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001", "AIBD-0265-source-0002", "AIBD-0265-source-0003" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The decoder combined low- and high-frequency brain activity and applied individually fitted click rules. The tablet ran Communicator 5." } }, "systems[].inputs_outputs": { "state": "value_present", "value": { "kind": "text", "text": "Electrical activity from the motor cortex became click commands in a scanning communication interface." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Electrical activity from the motor cortex became click commands in a scanning communication interface." } }, "systems[].model_name": { "state": "value_present", "value": { "kind": "text", "text": "A decoder based on normalized brain-signal power and fitted thresholds. No machine-learning model is identified." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A decoder based on normalized brain-signal power and fitted thresholds. No machine-learning model is identified." } }, "systems[].model_version": { "state": "not_reported", "provenance": { "kind": "source_review", "basis": "2016 Methods; 2024 Methods; thesis, p. 35.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "reason": "The papers do not report a decoder release. Activa PC+S and Communicator 5 identify hardware and application software.", "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The papers do not report a decoder release. Activa PC+S and Communicator 5 identify hardware and application software." } }, "systems[].product_name": { "state": "value_present", "value": { "kind": "text", "text": "Utrecht NeuroProsthesis, using Activa PC+S and Communicator 5." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Utrecht NeuroProsthesis, using Activa PC+S and Communicator 5." } }, "systems[].provider": { "state": "value_present", "value": { "kind": "text", "text": "UMC Utrecht developed the interface. Medtronic supplied the implant, and Tobii Dynavox supplied the communication software." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. 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The participant then selected letters or called for attention by attempting hand movements." }, "provenance": { "kind": "source_review", "basis": "Vansteensel et al. (2016), Methods and Results; Vansteensel et al. (2024), Methods and Results; Leinders (2025), pp. 35, 137–157.", "record_fields": [], "source_refs": [ "AIBD-0265-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A caregiver positioned the antenna and connected the tablet. The participant then selected letters or called for attention by attempting hand movements." } } }, "summary": { "total": 91, "addressed": 91, "known": 73, "reviewed": 81, "record_mapped": 7, "not_assessed": 3, "complete": false, "by_state": { "value_present": 73, "not_reported": 14, "unresolved": 1, "not_assessed": 3, "not_applicable": 0, "withheld": 0, "source_unavailable": 0 } } } }