AI system
- System
-
Utrecht NeuroProsthesis, using Activa PC+S and Communicator 5. [1]
- Model
-
A decoder based on normalized brain-signal power and fitted thresholds. No machine-learning model is identified. [1]
- Release
-
The papers do not report a decoder release. Activa PC+S and Communicator 5 identify hardware and application software. [1]
- Provider
-
UMC Utrecht developed the interface. Medtronic supplied the implant, and Tobii Dynavox supplied the communication software. [1]
- Role
-
The implant recorded brain activity. A decoder converted attempted movements into clicks for spelling and calling a caregiver. [1]
- Configuration
-
The decoder combined low- and high-frequency brain activity and applied individually fitted click rules. The tablet ran Communicator 5. [1] [2] [3]
- Inputs and outputs
-
Electrical activity from the motor cortex became click commands in a scanning communication interface. [1]
- Autonomy
-
The participant chose when to generate a click. The software scanned letters and converted her selections into text or a caregiver call. [1]
- Workflow
-
A caregiver positioned the antenna and connected the tablet. The participant then selected letters or called for attention by attempting hand movements. [1]
- Human oversight
-
Clinicians implanted and monitored the device. Researchers adjusted decoding settings, and caregivers helped set up and maintain the home equipment. [1]
- Relation to AI
-
Whether this interface uses AI remains unresolved. The documented decoder combines signal features and individually fitted thresholds. [1] [2] [3]
- AI contribution
-
Fitted signal-processing rules converted attempted hand movements into selections. The evidence supports this decoding contribution without identifying a learned AI model. [1]
Benefits
- Outcome identifiers
-
AIBD-0265-outcome-01 [1]
- Benefit
-
The participant could communicate and call a caregiver at home after training. [1]
- Category
-
Improved Accessibility
- Status
-
Observed in one participant over several years. [1]
- Beneficiary groups
-
People.
- Beneficiaries
-
One woman with advanced ALS who was 58 when she entered the study. [1]
- Reach
-
One participant, followed repeatedly. The two papers do not describe two separate beneficiaries. [1] [2]
- Distribution and access
-
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. [1]
- Duration
-
Independent home use lasted nearly seven years and ended in March 2023. [1]
- Expected?
-
Yes
- Costs and harms
-
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. [1]
Measurement
- Studies
-
NCT02224469 [1]
- Study design
-
A prospective single-participant study, followed by a longitudinal report on the same woman. [1]
- Measurement
-
Researchers tested clicks and spelling, collected satisfaction ratings, logged when the home system was available, and monitored brain signals and imaging. [1]
- Setting and sample
-
One participant at UMC Utrecht and in her home. Repeated task runs are observations from that same person. [1]
- Measures
-
Selection accuracy, spelling speed, time with the system available at home, satisfaction, and persistence of usable control. [1]
- Comparison
-
There was no control group. The participant also used an eye tracker until eye movement became unreliable. [1]
- Results
-
Initial spelling accuracy averaged 89%. With word prediction, she selected about two letters per minute. Home use continued for nearly seven years. [1] [2]
- Additional value from AI
-
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. [1]
- Limitations
-
The result concerns one person. Home logs show availability, not continuous active communication. Declining control coincided with ALS progression, without proving a single cause. [1]
- Denominators
-
The initial report describes 67 two-hour research sessions over 262 days. Home use without investigators began on day 197 after implantation. [1]
- Materials for replication
-
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. [1]
Money
- Kind of value
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Amount
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Currency and prices
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Period and unit
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Realization
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Recipients and payers
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Gross or net
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Included costs
-
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. [1]
- Comparison
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Method
-
The reviewed sources do not report a monetary valuation or financial return. [1]
- Return and payback
-
The reviewed sources do not report a monetary valuation or financial return. [1]
People and places
- Participants
-
UMC Utrecht researchers developed and evaluated the interface. Medtronic supplied the implant, and the participant and her caregivers used the home system. [1]
- Jurisdictions
-
Implantation, follow-up, and home use took place in the
Netherlands. [1] - Ownership and control
-
The reviewed clinical sources identify the organizations involved, but do not establish their complete ownership or control arrangements. [1]
- Dependencies
-
The system required implanted electrodes, a chest transmitter, an external antenna and receiver, a tablet, communication software, and continuing caregiver support. [1]
- Cross-border connections
-
The reviewed sources do not document international transfers of patient data or quantify cross-border financial flows. [1]
- Geopolitical implications
-
Not assessed
Follow-up
- Conditions for replication
-
Preserved motor signals, adequate cognition, caregiver support, individual training, and access to replacement equipment were necessary. [1]
- Replication attempts
-
The 2024 report follows the same woman, rather than a second user of this device. [2]
- Later findings
-
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. [2]
- Availability
-
The interface was investigational and used implant components off label. Replacement-device availability became a concern during follow-up. [1]
- Institutional decision
-
UMC Utrecht tested an implanted means of communication for people with severe paralysis. [1] [2]
- Grounds
-
The study received ethics approval and informed consent. Implant components were used off label. [1] [2]
Evidence
- Source numbers
-
3 retained sources.
- Language
-
English. No translation was used. [1]
- Source relationships
-
The investigators developed the interface. Medtronic supplied components and had a coauthor on the original report. The follow-up and thesis concern the same participant. [1] [2] [3]
- Original evidence
-
The original studies and their supporting materials are linked to the findings that they support. [1] [2] [3]
- Supported findings
-
The implant restored communication at home for nearly seven years, although the evidence does not establish a learned AI component. [1]
- Evidence links
-
The original paper establishes communication, the follow-up establishes its duration, and the thesis supplies decoder and safety details. [1] [2] [3]
- Evidence strength
-
Two peer-reviewed reports by the same developers followed one participant. The thesis supplies technical details, not independent replication. [1]
- Missing evidence
-
The sources do not establish a learned AI model or exact software release. Private messages and active home-use accuracy were deliberately excluded from logs. [1]
Grades
- Assessed benefits
-
The benefit described here, for the beneficiary groups shown.
- Depth
-
Depth 3 for restored communication that lasted nearly seven years.
- Reasons
-
Depth 3 for restored communication that lasted nearly seven years.
- Observed or intended
-
The depth describes the reported result. Evidence strength is assessed separately.
- Rubric
-
AIBD’s five-level depth rubric, reviewed on 25 October 2026.
- Assessor and date
-
AIBD, 25 October 2026.
- Alternative assessments
-
Depth 4 would require a separately established serious harm averted. The technical AI boundary remains distinct from the depth of the documented benefit.
- Fill
-
Peer-reviewed reports by the developers about one participant. The outline is retained.
Entry details
- Kind
-
A single-participant clinical study with long-term follow-up. [1]
- Related entries
-
AIBD-0052 cites this interface as a historical comparison. The two systems were not tested head to head.
- Field
-
Health; assistive communication. People with locked-in syndrome from ALS.
- Purpose
-
Provide autonomous communication for a person with late-stage ALS who could no longer rely on eye tracking
- Dates
-
Implantation began on 27 October 2015. Home use ended in March 2023. The follow-up report appeared on 14 August 2024. [1] [2]
- Stage
-
An investigational implant used at home after months of training. [1]
- Version
-
SHA-256: 6e096fc354b9…
References
- Other identifiers
-
NCT02224469 [1]
- Category mappings
-
Not assessed
- Brief
-
Not assessed
- Revisions
-
5 revisions. Latest: 25 October 2026.
Sources
-
Peer-reviewed study Developer
Vansteensel MJ, Pels EGM, Bleichner MG, et al. N Engl J Med 375:2060-2066 (2016)
Implantation date, hardware, individual training, task performance, home use, and donated components. Methods; Results; Discussion; data link.
Original report by developers and clinicians.
Supplement to the initial paper. Original parameter details could not be inspected directly. Later thesis details are identified as such. 2016 Supplementary Appendix.
Supplement to the initial paper.
Investigator-supplied registration. Actual trial and ethics identifiers. Identification, status, study design, and sponsor.
Investigator-supplied registration.
the patient accurately and independently controlled a computer typing program 28 weeks after electrode placement, at the equivalent of two letters per minute.
-
Peer-reviewed study Developer
Vansteensel MJ, Leinders S, Branco MP, et al. N Engl J Med 391:619-626 (2024)
Long-term use, end of reliable control, and limits of causal attribution. Methods; Results; Figures 1–2.
Follow-up of the same woman, not replication.
Publisher metadata for the same follow-up. First online publication on 14 August 2024; issue date 15 August 2024. Information: History.
Publisher metadata for the same follow-up.
-
Report Developer
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.
Investigator thesis; Chapter 6 reproduces the follow-up and supplement. Explicit threshold-based decoding, signal configuration, and adverse-event detail. p. 35; Chapter 6, pp. 137–157; Supplementary Table S1, p. 156.
Investigator thesis; Chapter 6 reproduces the follow-up and supplement.
Collections: Scrutiny and findings.