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Locked-In SyndromeUNPNCT02224469

First Study With a Brain Implant to Help Locked-in Patients Communicate at Home

A study testing ECoG (electrocorticography) sensing in people with Locked-In Syndrome, run by UMC Utrecht at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Locked-In Syndrome
What is being tested?
ECoG (electrocorticography) sensing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteNetherlands
Study dates
9 Sep 2015to 14 Feb 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 - 75
  • Locked-in status (i.e. severely paralyzed with communication problems)
  • in case of trauma or stroke: at least 1 year after the event
  • in case of a neuromuscular disease: slow progression allowed
  • Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech)
  • Mentally and physically capable of giving informed consent
Show all 15Show fewer
  • Lives in or close to the Netherlands
  • MR compatible
  • able to lie flat in the scanner
  • no metal objects in or attached to the body
  • no claustrophobia
  • Visus (largely) intact
  • Cognition intact (IQ>80)
  • Compatible with implantation procedure
  • good respiratory function or stable respiratory situation using ventilation assistance

Who cannot join

  • Strong and frequent spasms
  • Vital indication for blood thinners
  • Current brain tumor or history of tumor resection
  • Quick medical or neurological deterioration
  • Patients who are considered legally incapable (and who therefore will not be able to give informed consent)
  • Current or recent psychiatric disorder
  • Catabolic state
  • Allergy to the materials of the implant

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center

    Utrecht, 3584CX

Other trials in Netherlands

About this study

Official title: Utrecht Neural Prosthesis (UNP): A Pilot Study on Controllability of Brain Signals and Application in locked-in Patients

In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

Read the detailed description

In this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. For the first time, we will test whether we can record and decode neural signals obtained directly from the brain, for control over a computer. The target population is people with locked-in syndrome. For these patients there is no technique available to allow them to communicate unaided. We have developed a brain-computer interface (BCI) system that can read activity directly from the brain, and can convert the activity to a digital switch. The system, called the Utrecht Neural Prosthesis (UNP), consists of an implantable amplifier for electrical brain signals, a set of electrodes positioned on the surface of the brain and a wireless receiver, placed outside of the body. A dedicated computer will convert the signals to electrical pulses for standard Assistive Technology devices. The UNP can in principle enable the patient to engage in any activity that is offered by commercial Assistive Technology companies that can be performed with switch signals, for instance operating home apparatus or writing text. Most importantly, we aim to achieve unsupervised function of the BCI, meaning that the patient will be able to use it at home without the aid of researchers or other experts (but with minimal caregiver assistance).

Being tested
ECoG (electrocorticography) sensing
Keywords
Brain-Computer Interface, Motor Cortex, Dorsolateral Prefrontal Cortex, Quality of Life
Medical subject headings
Locked-In Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ECoG (electrocorticography) sensingDevice

    Also called Activa PC + S

    Implant electrodes and sensing device and use for control of Assistive Technology

Study groups in NCT02224469
Study groupRoleWhat they receive
ECoG (electrocorticography) sensingExperimentalUse ECoG-based Brain Computer interface to control assistive technology
Receives: Device: ECoG (electrocorticography) sensing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance

    The system correctly detects a switch brain signal within 10 sec in a real life, cognitively engaging context, such as operating a spelling device. A formal test has been designed, in which the patient has to copy a 30 character sentence within 30 minutes, with a margin of 20% faulty characters.

    Measured: up to 1 year

Secondary outcomes (4)

  1. Patient Device Satisfaction

    The Québec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0, a self-report or interview-based scale, designed to evaluate a person's satisfaction with a wide range of assistive technology, consisting of a 12 questions scale from 1(very dissatisfied) - 4(very satisfied). Reported is mean score. Higher scores are better.

    Measured: 8 years

  2. Effects Device on Quality of Life

    Psychosocial Impact of Assistive Devices Scale (PIADS), a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. Score range is -3 to 3, larger values indicate a more positive effect of the device. Outcome is averaged over three domains (competence, adaptability, and self-esteem)

    Measured: 3 years

  3. Quality of Life by Scoring Subjective Well-being in ACSA Score

    Anamnestic Comparative Self-Assessment (ACSA), a self-anchoring rating scale for subjective well-being score, ranges from -5 (worst period in life) to +5 (best period in life). Higher scores are a better outcome.

    Measured: 4.5 years

  4. Hours of Use of BCI Device Per Day

    The hours of use of the BCI device as determined by logging within the home use software. Only hours of use with full featured home use software and appropriate signal amplitude. The period where signal amplitude declined, possibly due to participants disease progression, is not taken into account.

    Measured: Time frame starts when participant receives a system with the full feature set for 24h home use and ends when signal decline starts influencing hours of use per day, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2014 (estimated)
  2. Study start9 Sep 2015
  3. Primary completion14 Feb 2024
  4. Study completion14 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02224469
Sponsor's protocol ID
UMCU 12-370
Other IDs
STW 12803
Acronym
UNP
Status last verified
Nov 2025
First submitted
21 Aug 2014
Last updated
3 Dec 2025
Data monitoring committee
Yes
Individual data sharing
Yes: selected datasets will be available through a public repository after publication of results

Publications

  • Vansteensel MJ, Hermes D, Aarnoutse EJ, Bleichner MG, Schalk G, van Rijen PC, Leijten FS, Ramsey NF. Brain-computer interfacing based on cognitive control. Ann Neurol. 2010 Jun;67(6):809-16. doi: 10.1002/ana.21985.

    PubMed 20517943

  • Torres Valderrama A, Paclik P, Vansteensel MJ, Aarnoutse EJ, Ramsey NF. Error probability of intracranial brain computer interfaces under non-task elicited brain states. Clin Neurophysiol. 2012 Dec;123(12):2392-401. doi: 10.1016/j.clinph.2012.05.006. Epub 2012 Jun 12.

    PubMed 22695047

  • Vansteensel MJ, Pels EGM, Bleichner MG, Branco MP, Denison T, Freudenburg ZV, Gosselaar P, Leinders S, Ottens TH, Van Den Boom MA, Van Rijen PC, Aarnoutse EJ, Ramsey NF. Fully Implanted Brain-Computer Interface in a Locked-In Patient with ALS. N Engl J Med. 2016 Nov 24;375(21):2060-2066. doi: 10.1056/NEJMoa1608085. Epub 2016 Nov 12.

    PubMed 27959736

  • Freudenburg ZV, Branco MP, Leinders S, van der Vijgh BH, Pels EGM, Denison T, van den Berg LH, Miller KJ, Aarnoutse EJ, Ramsey NF, Vansteensel MJ. Sensorimotor ECoG Signal Features for BCI Control: A Comparison Between People With Locked-In Syndrome and Able-Bodied Controls. Front Neurosci. 2019 Oct 16;13:1058. doi: 10.3389/fnins.2019.01058. eCollection 2019.

    PubMed 31680806

  • Pels EGM, Aarnoutse EJ, Leinders S, Freudenburg ZV, Branco MP, van der Vijgh BH, Snijders TJ, Denison T, Vansteensel MJ, Ramsey NF. Stability of a chronic implanted brain-computer interface in late-stage amyotrophic lateral sclerosis. Clin Neurophysiol. 2019 Oct;130(10):1798-1803. doi: 10.1016/j.clinph.2019.07.020. Epub 2019 Jul 27.

    PubMed 31401488

  • Pels EGM, Aarnoutse EJ, Ramsey NF, Vansteensel MJ. Estimated Prevalence of the Target Population for Brain-Computer Interface Neurotechnology in the Netherlands. Neurorehabil Neural Repair. 2017 Jul;31(7):677-685. doi: 10.1177/1545968317714577. Epub 2017 Jun 22.

    PubMed 28639486

  • Leinders S, Vansteensel MJ, Branco MP, Freudenburg ZV, Pels EGM, Van der Vijgh B, Van Zandvoort MJE, Ramsey NF, Aarnoutse EJ. Dorsolateral prefrontal cortex-based control with an implanted brain-computer interface. Sci Rep. 2020 Sep 22;10(1):15448. doi: 10.1038/s41598-020-71774-5.

    PubMed 32963279

  • Leinders S, Vansteensel MJ, Piantoni G, Branco MP, Freudenburg ZV, Gebbink TA, Pels EGM, Raemaekers MAH, Schippers A, Aarnoutse EJ, Ramsey NF. Using fMRI to localize target regions for implanted brain-computer interfaces in locked-in syndrome. Clin Neurophysiol. 2023 Nov;155:1-15. doi: 10.1016/j.clinph.2023.08.003. Epub 2023 Aug 18.

    PubMed 37657190

  • Vansteensel MJ, Leinders S, Branco MP, Crone NE, Denison T, Freudenburg ZV, Geukes SH, Gosselaar PH, Raemaekers M, Schippers A, Verberne M, Aarnoutse EJ, Ramsey NF. Longevity of a Brain-Computer Interface for Amyotrophic Lateral Sclerosis. N Engl J Med. 2024 Aug 15;391(7):619-626. doi: 10.1056/NEJMoa2314598.

    PubMed 39141854

  • Leinders S, Aarnoutse EJ, Branco MP, Freudenburg ZV, Geukes SH, Schippers A, Verberne MSW, van den Boom M, van der Vijgh B, Crone NE, Denison T, Ramsey NF, Vansteensel MJ. DO NOT LOSE SLEEP OVER IT: IMPLANTED BRAIN-COMPUTER INTERFACE FUNCTIONALITY DURING NIGHTTIME IN LATE-STAGE AMYOTROPHIC LATERAL SCLEROSIS. medRxiv [Preprint]. 2024 Oct 15:2024.10.11.24315027. doi: 10.1101/2024.10.11.24315027.

    PubMed 39484239

Questions about this trial

What is this clinical trial studying?

A study testing ECoG (electrocorticography) sensing in people with Locked-In Syndrome, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02224469, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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