Investigation on the Cortical Communication System

NCT06207591 | Recruiting DMC

• 2 other identifiers: UMCU 23-171NL81205.041.23
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems. The main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI. Participants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 times per week for one year. Extension of participation after one year is possible. If successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.

Conditions

Locked-in Syndrome; Neuromuscular Diseases; Brainstem Stroke; Traumatic Brain Injury

Keywords

Locked-in; Amyotrophic lateral sclerosis; Neurodegenerative disease

Outcome Measures

Primary Outcomes (8)

• Usability of the BCI system - Accuracy

  Accuracy: \>80% sensitivity (true positive rate) for 1-command control, and 90% sensitivity and 80% classification accuracy (distinguishing between the six classes) for 6-command control

  1 year

• Usability of the BCI system - speed

  Speed characters or keywords per minute

  1 year

• Usability of the BCI system - subjective workload Visual Analogue Scale (VAS)

  Subjective Workload: Visual Analogue Scale Continuous scale: Little to no effort (0) - Much effort (5). Lower numbers are better.

  1 year

• Usability of the BCI system - subjective workload National Aeronautics and Space Administration-Task Load Index (NASA-TLX)

  Subjective Workload: National Aeronautics and Space Administration-Task Load Index Scale: 21 point Likert-type scale. Lower numbers are better.

  1 year

• Usability of the BCI system - user satisfaction Psychosocial impact of assistive devices scale (PIADS)

  User Satisfaction: Psychosocial impact of assistive devices scale. Likert-type scale -3, -2, -1, 0, 1, 2, 3. 3 is best result.

  1 year

• Usability of the BCI system - user satisfaction Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

  User Satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology version 2.0. Likert-type scale: Extremely dissatisfied - Dissatisfied - Slightly satisfied - Satisfied - Extremely satisfied. Extremely Satisfied is the best result.

  1 year

• Usability of the BCI system - validation

  Validation: Questionnaire to evaluate user satisfaction and ease of use of the home use software. Likert-type scale: fully disagree - disagree - neither agree or disagree - agree - fully agree - not applicable. Fully agree is the best result.

  1 year

• Degrees of Freedom of BCI Control.

  the number of different commands that are successfully decoded, or the size of the decoded vocabulary

  1 year

Secondary Outcomes (5)

• Stability of BCI performance (electrode-tissue interaction)

  2 years

• Stability of BCI performance (signal)

  2 years

• Stability of BCI performance (modulation)

  2 years

• Stability of BCI performance (performance)

  2 years

• Independent use of BCI

  2 years

Other Outcomes (1)

• Assess device specifications for future application of HD ECoG-BCIs

  2 years

Study Arms (1)

ECoG (electrocorticography) sensing

EXPERIMENTAL

Use implantable ECoG-based Brain Computer interface to control assistive technology

Device: ECoG (electrocorticography) sensing

Interventions

ECoG (electrocorticography) sensing DEVICE

Implant electrodes and pedestal connector and use, through amplifier and decoding, for control of BCI

Also known as: CortiCom-Utrecht assembly

ECoG (electrocorticography) sensing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Clinical diagnosis of locked-in state state or likelihood of soon progressing into LIS (within an estimated 2 years), caused by traumatic brain injury, brainstem stroke, neurodegenerative disease, neuromuscular disease or another cause
• Current or imminent complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis)
• Current or imminent motor-related speech impairment (dysarthria or anarthria)
• Either receiving tracheostomy invasive ventilation, or having a stable and adequate respiratory situation without respiratory support, allowing for safe intubation, mechanical ventilation and detubation during surgery according to the involved clinicians, and, if relevant (e.g., in case of a progressive condition), in combination with a confirmed desire to receive tracheostomy invasive ventilation when that becomes necessary
• Meeting surgical safety criteria, including surgical clearance by the study physicians
• Meeting (neuro)psychological evaluation criteria
• Ability to communicate reliably, such as through eye movement
• Willingness and ability to provide informed consent
• Lives within reasonable distance from University Medical Center Utrecht
• Participant consents to the study and still wishes to participate at the time of the study
• Vision and hearing largely intact

You may not qualify if:

• Performance on formal neuropsychological testing that indicates a significant current or recent psychiatric disorder, cognitive or behavioral impairment, that would interfere with obtaining informed consent or fully participating in study activities
• Medical conditions contraindicating surgery of a chronically implanted device or that could interfere with study participation (for example active infections, unexplained fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, cranioplasty, significant cardiovascular, metabolic, or renal impairments, chronic oral or intravenous use of steroids or immunosuppressive therapy, active cancer within the past year or requires chemotherapy, uncontrolled autonomic dysreflexia within the past 3 months, hydrocephalus with or without an implanted ventricular shunt or a medical contraindication to stop anti-coagulant medications during surgery)
• Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations too challenging or incompatible with desired risk levels
• Inability to undergo MRI for pre-implantation evaluation, for example due to the presence of implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants
• Anticipated need for MRI after implantation of the CortiCom assembly

Sponsors & Collaborators

• UMC Utrecht: lead
• Johns Hopkins University: collaborator

Study Sites (1)

University Medical Center

Utrecht, 3584CX, Netherlands

RECRUITING

Related Publications (3)

• 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 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 BACKGROUND

• The neural representation of fine hand movements in an individual approaching locked-in syndrome (2025) S.H. Geukes, A. Bekius, M.P. Branco, M.S.W. Verberne, A. Schippers, Z.V. Freudenburg, E.J. Aarnoutse, M.J. Vansteensel, N.E. Crone, N.F. Ramsey. 11th International BCI Meeting, Banff, Canada, DOI: 10.3217/978-3-99161-050-2-085

  RESULT

MeSH Terms

Conditions

Locked-In Syndrome; Neuromuscular Diseases; Brain Stem Infarctions; Brain Injuries, Traumatic; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases

Interventions

Electrocorticography

Condition Hierarchy (Ancestors)

Quadriplegia; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nick F Ramsey, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariska J Vansteensel, PhD

CONTACT

+31887555121; neuroprothese@umcutrecht.nl

Erik J Aarnoutse, PhD

CONTACT

+31887555123; e.j.aarnoutse@umcutrecht.nl

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: December 1, 2023
• First Posted: January 17, 2024
• Study Start: December 15, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: after first published results, no end date
• Access Criteria: Publicly available

Locations

NL (1)