Innovative Brain-Computer Interface for People With Spinal Cord Injury

NCT07640711 | Recruiting DMC

• 2 other identifiers: NL-009756METC nummer 25-211
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to demonstrate control of digital devices through a brain implant in people with spinal cord injury. The main question it aims to answer is efficient, independent, BCI-based control over digital devices in settings of daily living of an individual with SCI. In this project an advanced generation fully implantable BCI system will be used, the Brain InterChange (BIC) from CorTec. Participants will be implanted with an electrode grid on the surface of the brain and an amplifier/transmitter on the skull, under the skin. Participation includes visits of researchers for recording and training at home, 1-3 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

Spinal Cord Injury; Tetraplegia C1-C4; Quadriplegia

Outcome Measures

Primary Outcomes (11)

• Effectiveness of BCI Control: Accuracy

  Accuracy: \>80% sensitivity (true positive rate) for 1-command control; 80% classification accuracy (distinguishing between multiple classes) for multi-command control; and 80% classification accuracy and the correlation between the intended and actual response for multi-command continuous control

  1 year

• Efficiency of BCI control: Speed

  number of accurate selections made per minute

  1 year

• Efficiency of BCI control: Subjective Workload - Visual Analogue Scale

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

  1 year

• Efficiency of BCI control: Subjective Workload - National Aeronautics and Space Administration-Task Load Index

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

  1 year

• 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

• 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

• Stability of BCI performance: impedance

  Longitudinally follow the electrode impedance (in Ω), to assess their stability throughout the day and across the weeks and months after implantation.

  1 year

• Stability of BCI performance: signal dynamics

  Longitudinally follow the raw signal dynamics (in µV) of neural signals, to assess their stability throughout the day and across the weeks and months after implantation.

  1 year

• Stability of BCI performance: task-related modulation

  Longitudinally follow the task-related modulation in power (in µV), to assess their stability throughout the day and across the weeks and months after implantation.

  1 year

• Effects of somatosensory feedback on BCI Training and Performance: accuracy

  Compare BCI control accuracy (in %), including variability and improvement therein before and after applying somatosensory feedback through electrocortical stimulation of the somatosensory cortex

  1 year

• Effects of somatosensory feedback on BCI Training and Performance: neural signals

  Compare neural signal changes (in µV) in the sensorimotor areas before and after applying somatosensory feedback through electrocortical stimulation of the somatosensory cortex

  1 year

Secondary Outcomes (2)

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

  1 year

• Validation of software for independent home-use of advanced BCIs

  1 year

Study Arms (1)

ECoG (electrocorticography) sensing

EXPERIMENTAL

Use implantable ECoG-based Brain Computer interface to control digital devices

Device: ECoG (electrocorticography) sensing

Interventions

ECoG (electrocorticography) sensing DEVICE

Implant electrodes and amplifier/transmitter and use, through amplifier and decoding, for control of BCI

Also known as: Brain Interchange

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:

• Clinical diagnosis of SCI at the cervical level C4 or higher (C1-C4)
• Complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis), i.e., level A or B at the American Spinal Injury Association (ASIA) Impairment Scale
• Meeting surgical safety criteria, including surgical clearance by the study physicians
• Meeting (neuro)psychological evaluation criteria
• Ability to communicate reliably, via speech or other means
• Willingness and ability to provide informed consent.
• Lives within reasonable distance from UMC Utrecht
• Participant consents to the study and still wishes to participate at the time of the study.
• Vision and hearing largely intact.
• For candidates who are not currently receiving invasive ventilation, and who have current respiratory problems (e.g., at night), there should be a clear and confirmed desire to proceed with tracheostomy ventilation whenever that would become necessary.

You may not qualify if:

• Having a spinal cord injury with a degenerative or progressive etiology.
• Having evident swallowing problems.
• Having a significant current or recent anxiety disorder or depression or cognitive 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, or a catabolic state, or strong and frequent spasms)
• 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 or devices that deliver diaphragm pacing.
• Anticipated need for MRI after implantation of the Brain InterChange system.

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, 3584CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Electrocorticography

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: Researcher

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 11, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

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

Locations

NL (1)