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

NCT02224469 | Completed Results DMC

• 2 other identifiers: UMCU 12-370STW 12803
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Locked-In Syndrome

Keywords

Brain-Computer Interface; Motor Cortex; Dorsolateral Prefrontal Cortex; Quality of Life

Outcome Measures

Primary Outcomes (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.

  up to 1 year

Secondary Outcomes (4)

• Patient Device Satisfaction

  8 years

• Effects Device on Quality of Life

  3 years

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

  4.5 years

• Hours of Use of BCI Device Per Day

  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

Other Outcomes (1)

• Supervised BCI Performance

  up to 28 weeks

Study Arms (1)

ECoG (electrocorticography) sensing

EXPERIMENTAL

Use ECoG-based Brain Computer interface to control assistive technology

Device: ECoG (electrocorticography) sensing

Interventions

ECoG (electrocorticography) sensing DEVICE

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

Also known as: Activa PC + S

ECoG (electrocorticography) sensing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center

Utrecht, 3584CX, Netherlands

Location

Related Publications (10)

• 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.

  PMID: 20517943 BACKGROUND

• 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.

  PMID: 22695047 BACKGROUND

• 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.

  PMID: 27959736 RESULT

• 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.

  PMID: 31680806 RESULT

• 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.

  PMID: 31401488 RESULT

• 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.

  PMID: 28639486 RESULT

• 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.

  PMID: 32963279 RESULT

• 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.

  PMID: 37657190 RESULT

• 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.

  PMID: 39141854 RESULT

• 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.

  PMID: 39484239 DERIVED

Related Links

• Related Info for laymen
• Info on research group

MeSH Terms

Conditions

Locked-In Syndrome

Interventions

Electrocorticography

Condition Hierarchy (Ancestors)

Quadriplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Results Point of Contact

• Title: Dr E.J. Aarnoutse
• Organization: University Medical Center Utrecht

e.j.aarnoutse@umcutrecht.nl

+31887555123

Study Officials

• Nick F Ramsey, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: September 9, 2015
• Primary Completion: February 14, 2024
• Study Completion: February 14, 2024
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: From Nov 14, 2016, no end date
• Access Criteria: According to http://datadryad.org/pages/policies

Locations

NL (1)