{ "id": "AIBD-0052", "title": "People with severe paralysis regained control of a computer at home", "summary": "Two people with ALS regained control of a computer at home using Stentrode and eye tracking.", "date_observed": "2020-10-28", "date_basis": "source publication", "date_precision": "day", "benefit_status": "reported", "source_collection": null, "source_entry": null, "account": "Two people with ALS received a Stentrode implant at the Royal Melbourne Hospital. Attempted movements generated computer clicks, while an eye tracker moved the cursor. Participant 1 used a support-vector machine, and participant 2 used a manually tuned threshold classifier. They began use at home without research staff on days 86 and 71 after implantation, although a caregiver still helped set up the system. Both could text, shop, and check finances. A later report followed four implanted participants, including the original two, for 12 months. It reported no serious device-related events and eight mild device effects.", "category": "benefit created", "unexpected": false, "purpose": "Restore digital device control for people with severe paralysis without open-brain surgery", "system": "Synchron Stentrode with a participant-specific decoder and Tobii Dynavox eye tracking", "model_version": null, "developer": "Synchron Inc. with the University of Melbourne", "deployer": "Royal Melbourne Hospital (implantation and follow-up); participants' homes (use)", "location": "Melbourne, Australia", "domain": "Neurotechnology / assistive communication", "segment": "People with ALS and severe upper-limb paralysis", "benefit_type": "Improved Accessibility", "taxonomy_note": null, "registry_ids": { "clinicaltrials_gov": "NCT03834857" }, "ratings": [ { "group": "personal", "depth": 3, "reason": "Participants regained sustained control of everyday computer tasks at home. No separate societal outcome was measured." } ], "ai_role": { "status": "assessed", "statement": "Participant 1 used a support-vector machine trained on movement attempts. Participant 2 used a manually tuned threshold classifier. Both converted brain signals into clicks, while an eye tracker handled cursor movement. The measured benefit belonged to the combined system." }, "evidence": [ { "kind": "peer-reviewed study", "citation": "Oxley TJ, Yoo PE, Rind GS, et al. (2021). Motor neuroprosthesis implanted with neurointerventional surgery improves capacity for activities of daily living tasks in severe paralysis: first in-human experience. Journal of NeuroInterventional Surgery 13(2):102-108.", "title": "Motor neuroprosthesis implanted with neurointerventional surgery improves capacity for activities of daily living tasks in severe paralysis: first in-human experience", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7848062/", "date": "2020-10-28", "written_by": "makers", "quote": "Completion of IADL tasks including text messaging, online shopping and managing finances independently was demonstrated in both participants." }, { "kind": "peer-reviewed study", "citation": "Peter Mitchell et al., “Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study,” JAMA Neurology 80, no. 3 (2023): 270–278, doi:10.1001/jamaneurol.2022.4847. Published online January 9, 2023.", "title": "Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients: The Stentrode With Thought-Controlled Digital Switch (SWITCH) Study", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC9857731/", "date": "2023-01-09", "written_by": "makers", "quote": null } ], "replication": { "produced_by": [ "An implanted electrode array recorded attempted movements.", "A participant-specific decoder converted signals into computer clicks.", "Eye tracking supplied cursor movement, and caregivers helped with setup." ], "must_hold": [ "Suitable venous anatomy and preserved motor-cortex activity.", "Clinical follow-up, training, caregiver assistance, and antiplatelet treatment." ], "echoes": [ { "date": "2023-01-09", "setting": "The same SWITCH study, expanded to four implanted participants", "model_version": null, "outcome": "recurred", "source": "Mitchell et al. (2023), doi:10.1001/jamaneurol.2022.4847. The first two participants overlap with the earlier report." } ] }, "paired_incident": null, "headline": "People with severe paralysis regained control of a computer at home", "metric": "typed 13.81 and 20.10 correct characters per minute", "comparator": { "against": "An earlier, separate study of the Utrecht implanted interface", "before": "Home use began 197 days after implantation in that earlier participant", "after": "Home use began on days 86 and 71 in the two Stentrode participants", "basis": "measured", "quote": "The current study achieved unsupervised home use of multiple-click actions within 86 days (participant 1) and 71 days (participant 2) of neurointerventional surgery.", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7848062/" }, "later": { "status": "persisted", "date": "2023-01-09", "note": "A report covering four implanted participants, including the original two, found no serious device-related events during 12 months of follow-up. Eight mild device effects occurred.", "quote": null, "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC9857731/" }, "value": null, "developer_country": "United States", "deployer_country": "Australia", "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": "2026-10-20", "change": "Replaced “two men” with “two people” in the title and account because no cited source gives the participants' sex; added the paper's implant timing (mid-2019 and early 2020) and an explicit note that the publication date stands in for the date observed; renamed the model version to the paper's own registration (NCT03834857) because the JNIS paper never uses the SWITCH name; and treated Mitchell 2023 as independent because its lead and senior authors are Royal Melbourne Hospital investigators.", "source": "Oxley et al. (2021) J NeuroInterv Surg, PMC7848062; Mitchell et al. (2023) JAMA Neurology, PMID 36622685; RMH statement 24 January 2023", "editor": "AIBD" }, { "date": "2026-10-21", "change": "Added what the benefit is measured against, what happened since from the cited sources.", "source": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7848062/; https://europepmc.org/abstract/MED/36622685", "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://synchron.com/news; https://en.wikipedia.org/wiki/Royal_Melbourne_Hospital", "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": "2026-10-25", "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/PMC7848062/", "editor": "AIBD" } ], "confidence": "claimed", "shade": "low", "claim_status": "The makers' claim", "claim_basis": "Sources: two peer-reviewed studies from the makers. The cited evidence includes no independent source and no finding by a regulator or court.", "profile": { "case_id": "AIBD-0052", "catalog_version": "1.0.0", "source_fingerprint": "1bedfa433679e79d0899a74679fd4d86a39e5fc243628f6951ae8a1aa7d24871", "collection_refs": [ { "collection_id": "aibd", "version": "snapshot-8bf7cfec9cb185aa" }, { "collection_id": "aibd", "version": "2026-10-25" }, { "collection_id": "viator", "version": "2026-10-25" } ], "source_ids": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "families": { "strategic assessments": { "state": "not_assessed", "review_state": "not_assessed", "coverage": "partial", "record_ids": [] }, "evaluations": { "state": "value_present", "value": { "kind": "identifiers", "identifiers": [ "NCT03834857" ], "role": "evaluations" }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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Evidence strength is assessed separately." }, "provenance": { "kind": "curatorial", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-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": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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The studies were not head-to-head." }, "provenance": { "kind": "curatorial", "basis": "2020 Discussion.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD-0265 describes the Utrecht interface cited as a historical comparison. The studies were not head-to-head." } }, "claims[].evidence_links": { "state": "value_present", "value": { "kind": "structured", "data": { "initial_abilities": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7848062/", "locator": "Results" }, "decoder_difference": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC7848062/", "locator": "Supplementary Appendix, pp. 6–8" }, "follow_up": { "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC9857731/", "locator": "Results and Table 2" } } }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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(2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "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": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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(2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "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": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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(2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "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": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "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": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "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": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "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 use of the combined implant, decoder, eye tracker, and software. It does not isolate the benefit of machine learning." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The study demonstrates use of the combined implant, decoder, eye tracker, and software. It does not isolate the benefit of machine learning." } }, "evaluations[].comparator": { "state": "value_present", "value": { "kind": "text", "text": "There was no concurrent control. The comparison with the Utrecht interface involved different participants and protocols." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "There was no concurrent control. The comparison with the Utrecht interface involved different participants and protocols." } }, "evaluations[].design": { "state": "value_present", "value": { "kind": "text", "text": "A prospective, open-label feasibility study without a control group. The later report includes the first two participants." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "A prospective, open-label feasibility study without a control group. The later report includes the first two participants." } }, "evaluations[].effect": { "state": "value_present", "value": { "kind": "structured", "data": { "first_two": { "selection_accuracy_percent": [ 92.63, 93.18 ], "correct_characters_per_minute": [ 13.81, 20.1 ] }, "later_four": { "selection_accuracy_mean_percent": 93.9, "selection_accuracy_SD": 1.8, "correct_characters_per_minute_mean": 16.6, "correct_characters_per_minute_SD": 5.6, "device_related_serious_events": 0, "mild_device_effects": 8, "follow_up_months": 12, "mild_effect_types": [ "Bruising", "Anemia", "Hematoma", "Postoperative fatigue" ] }, "initial_procedure_event": { "participant": 1, "event": "Brief syncope with two sinus pauses", "pause_seconds": [ 7.5, 6 ], "resolved": "Consciousness returned within 10 seconds; no intervention required." } } }, "provenance": { "kind": "source_review", "basis": "2020 Results; 2023 Results and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The first two participants typed 13.81 and 20.10 correct characters per minute, with selection accuracy above 92%." } }, "evaluations[].exposure": { "state": "value_present", "value": { "kind": "text", "text": "The first participants began home use without research staff on days 86 and 71 after implantation. Caregiver assistance with setup remained necessary." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The first participants began home use without research staff on days 86 and 71 after implantation. Caregiver assistance with setup remained necessary." } }, "evaluations[].id": { "state": "value_present", "value": { "kind": "text", "text": "NCT03834857" }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "NCT03834857" } }, "evaluations[].measurement_method": { "state": "value_present", "value": { "kind": "text", "text": "Researchers measured typing and selection accuracy, observed everyday computer tasks, recorded adverse events, and checked vessel patency and device position." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Researchers measured typing and selection accuracy, observed everyday computer tasks, recorded adverse events, and checked vessel patency and device position." } }, "evaluations[].metric": { "state": "value_present", "value": { "kind": "text", "text": "Correct characters per minute, selection accuracy, completion of everyday tasks, serious device-related events, vessel occlusion, and migration." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Correct characters per minute, selection accuracy, completion of everyday tasks, serious device-related events, vessel occlusion, and migration." } }, "evaluations[].reproduction_materials": { "state": "value_present", "value": { "kind": "text", "text": "The 2020 supplement gives participant-specific filters, training splits, and click rules. It does not publish exact trained weights or a software release." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The 2020 supplement gives participant-specific filters, training splits, and click rules. It does not publish exact trained weights or a software release." } }, "evaluations[].setting_sample": { "state": "value_present", "value": { "kind": "text", "text": "Two implanted participants appeared in the first report. The later study enrolled five people, implanted four, and excluded one because of venous anatomy." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Two implanted participants appeared in the first report. The later study enrolled five people, implanted four, and excluded one because of venous anatomy." } }, "evaluations[].uncertainty_limitations": { "state": "value_present", "value": { "kind": "text", "text": "The cohort was small and selected, and decoders differed between participants. Without a control group, superiority over other assistive systems cannot be established." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The cohort was small and selected, and decoders differed between participants. Without a control group, superiority over other assistive systems cannot be established." } }, "external_references[]": { "state": "value_present", "value": { "kind": "structured", "data": { "ClinicalTrials.gov": "NCT03834857" } }, "provenance": { "kind": "source_review", "basis": "Original study registration, inspected through the ClinicalTrials.gov API.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "NCT03834857" } }, "follow_up[]": { "state": "value_present", "value": { "kind": "text", "text": "The four-person follow-up found no serious device-related events over 12 months. Eight mild device effects occurred, and one participant later demonstrated texting without eye tracking." }, "provenance": { "kind": "source_review", "basis": "2023 Results: Safety and Feasibility end points; Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The four-person follow-up found no serious device-related events over 12 months. Eight mild device effects occurred, and one participant later demonstrated texting without eye tracking." } }, "human_oversight": { "state": "value_present", "value": { "kind": "text", "text": "Clinicians selected and implanted participants, monitored safety, and managed antiplatelet treatment. Researchers tuned decoders, and caregivers helped with setup at home." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Clinicians selected and implanted participants, monitored safety, and managed antiplatelet treatment. Researchers tuned decoders, and caregivers helped with setup at home." } }, "id": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "id": "AIBD-0052" } }, "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 implantation, a chest receiver, a computer, eye tracking, individual training, caregiver support, and clinical follow-up." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The system required implantation, a chest receiver, a computer, eye tracking, individual training, caregiver support, and clinical follow-up." } }, "outcomes[].beneficiaries": { "state": "value_present", "value": { "kind": "text", "text": "People with severe upper-limb paralysis who retained suitable brain activity and venous anatomy." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "People with severe upper-limb paralysis who retained suitable brain activity and venous anatomy." } }, "outcomes[].beneficiary_count": { "state": "value_present", "value": { "kind": "structured", "data": { "initial_report_implanted": 2, "later_report_enrolled": 5, "later_report_implanted": 4, "overlap": 2, "unique_implanted_total": 4, "typing_observations_initial": { "participant_1": { "selections": 748, "trials": 129 }, "participant_2": { "selections": 569, "trials": 95 } } } }, "provenance": { "kind": "source_review", "basis": "2020 Results; 2023 Methods and Results.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Four unique implanted participants are described across both reports. The initial two are included in the later four." } }, "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": "Participants regained the ability to select items and perform everyday computer tasks at home." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Participants regained the ability to select items and perform everyday computer tasks at home." } }, "outcomes[].distribution": { "state": "value_present", "value": { "kind": "text", "text": "The four implanted participants were men of European ancestry. The small, selected group does not establish broad suitability." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The four implanted participants were men of European ancestry. The small, selected group does not establish broad suitability." } }, "outcomes[].duration": { "state": "value_present", "value": { "kind": "text", "text": "The original report covered 12 months for participant 1 and three months for participant 2. The later paper followed four implanted participants for 12 months each." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The original report covered 12 months for participant 1 and three months for participant 2. The later paper followed four implanted participants for 12 months each." } }, "outcomes[].id": { "state": "value_present", "value": { "kind": "text", "text": "AIBD-0052-outcome-01" }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "AIBD-0052-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-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "People." } }, "outcomes[].status": { "state": "value_present", "value": { "kind": "text", "text": "Demonstrated in a small, uncontrolled clinical study." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Demonstrated in a small, uncontrolled clinical study." } }, "outcomes[].tradeoffs": { "state": "value_present", "value": { "kind": "text", "text": "Implantation required anesthesia and antiplatelet treatment. One participant fainted briefly after surgery. The later four-person report recorded eight mild device effects." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Implantation required anesthesia and antiplatelet treatment. One participant fainted briefly after surgery. The later four-person report recorded eight mild device effects." } }, "outcomes[].unexpected": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "unexpected": false, "purpose": "Restore digital device control for people with severe paralysis without open-brain surgery" } }, "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": "The first clinical study and home use took place in Melbourne, Australia. Synchron was based in the United States and worked with Australian investigators." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The first clinical study and home use took place in Melbourne, Australia. Synchron was based in the United States and worked with Australian investigators." } }, "purpose": { "state": "value_present", "value": { "kind": "record_fields", "fields": { "purpose": "Restore digital device control for people with severe paralysis without open-brain surgery" } }, "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": { "initial_publication": "2020-10-28", "follow_up_publication": "2023-01-09", "first_participant_implant": "mid-2019", "second_participant_implant": "early 2020", "precision_of_individual_implants": "part-year only" } }, "provenance": { "kind": "source_review", "basis": "2020 Results; 2023 publisher online-publication metadata.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001", "AIBD-0052-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The first implants occurred in mid-2019 and early 2020. The initial report appeared on 28 October 2020." } }, "replication.attempts[]": { "state": "value_present", "value": { "kind": "structured", "data": { "study": "NCT03834857", "first_report": 2, "later_report": 4, "overlapping_participants": 2, "independent_replication": false } }, "provenance": { "kind": "source_review", "basis": "2023 Introduction and Results.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0002" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "The later four-person report includes the original two participants." } }, "replication.conditions": { "state": "value_present", "value": { "kind": "text", "text": "Suitable anatomy, preserved motor signals, training, caregiver setup, and continuing clinical care were required." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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The second used a threshold that changed during typing. Both produced short and held clicks." } }, "systems[].inputs_outputs": { "state": "value_present", "value": { "kind": "text", "text": "Electrical signals recorded from a cerebral vein were converted into no click, a short click, or a held click." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. 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NCT03834857 identifies the trial, not the model." } }, "systems[].product_name": { "state": "value_present", "value": { "kind": "text", "text": "Stentrode, with a custom decoder and Tobii Dynavox software." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. Mitchell et al. (2023), Methods, Results, and Table 2.", "record_fields": [], "source_refs": [ "AIBD-0052-source-0001" ], "reviewed_on": "2026-10-25" }, "review_state": "reviewed", "coverage": "complete", "display": { "answer": "Stentrode, with a custom decoder and Tobii Dynavox software." } }, "systems[].provider": { "state": "value_present", "value": { "kind": "text", "text": "Synchron supplied Stentrode. The research team developed the decoding method, and Tobii Dynavox supplied eye tracking and computer-access software." }, "provenance": { "kind": "source_review", "basis": "Oxley et al. (2020), Results and Methods; Supplementary Appendix, pp. 3–10. 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