An implanted interface restored communication for nearly seven years

A woman with locked-in ALS used the Utrecht NeuroProsthesis to communicate at home for nearly seven years.

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]

Action and result

Clinicians implanted the system and researchers supported its use and adaptation at home. [1] [2]

Success criterion

Researchers evaluated communication control, usability, and long-term stability. The case report did not define a single financial or clinical pass threshold. [1] [2]

Evidence

Source numbers

3 retained sources.

Citations

Original citations and the passages that support each finding. [1] [2] [3]

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]

Access and versions

Access and version details are listed for each reviewed source. [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 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]

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

  1. 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.

  2. 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.

  3. 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.