Innovative Brain-Computer Interface for People With Spinal Cord Injury (INTENSE-BCI)

Innovative Neurotechnology For Society - Brain-Computer Interface

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injury; Quadriplegia; Tetraplegia C1-C4
• Intervention / Treatment: Device: ECoG (electrocorticography) sensing

Detailed Description

Spinal Cord Injury (SCI) results in motor impairments in body parts innervated by the spinal cord below the site of the lesion. In addition to loss of leg movements, individuals with high cervical SCI experience significant impairments in arm and hand function (tetraplegia), impacting their access to digital devices, with obvious consequences for their ability to communicate, participate in society and the workforce, autonomously manage their life, and benefit from the entertainment options digital devices offer these days. Current assistive technologies (AT) for control over digital devices, such as voice control, eye-tracking, and head- or mouth-controlled devices, are often unintuitive, slow, limited in functionality, aesthetically unattractive, and they often interfere with regular movement or speech. An effective Brain-Computer Interface (BCI) would enable individuals with SCI to use movement-related neural signals to directly control digital devices, taking away the disadvantages of current AT. This would dramatically improve their quality of life.

The Brain InterChange from CorTec is an active implantable medical device for measurement of neuronal activity and electrical stimulation of the human nervous system, comprising an internal and an external unit. The internal unit consists of a small high-density ECoG grid with 32 contacts placed subdurally and a connected implantable amplifier/transmitter device that is placed subcutaneously. The external unit comprises a headpiece, for power transmission to the internal unit, a communication unit, that receives the data transmitted from the internal unit and controls the power transmission, and a USB cable, that connects the communication unit to the computer that has software to process and translate the brain data to a means of digital device control for SCI patients with custom in-house software developed during this study.

The BCI system also allows to provide users with somatosensory feedback about their motor attempts (in addition to the visual feedback), by delivering electrocortical stimulation (ECS) to the somatosensory regions of the brain. As such, the aim is to generate a more natural relation between intent (movement attempt of a body part) and effect (sensation in the same body part), which is expected to lead to fast training and accurate BCI performance.

• Study Type: Interventional
• Enrollment (Estimated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariska J Vansteensel, PhD; Phone Number: +31887555121; Email: neuroprothese@umcutrecht.nl
• Study Contact Backup: Name: Erik J Aarnoutse, PhD; Phone Number: +31887555123; Email: e.j.aarnoutse@umcutrecht.nl

Study Locations

• Netherlands
  • Utrecht
    • Utrecht, Utrecht, Netherlands, 3584CX
      • Recruiting
      • University Medical Center Utrecht
      • Contact: Mariska J Vansteensel, PhD; Phone Number: +31887555121; Email: neuroprothese@umcutrecht.nl
      • Contact: Erik J Aarnoutse, PhD; Phone Number: +31887555123; Email: e.j.aarnoutse@umcutrecht.nl
      • Principal Investigator: Nick F Ramsey, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECoG (electrocorticography) sensing; Use implantable ECoG-based Brain Computer interface to control digital devices	Device: ECoG (electrocorticography) sensing; Implant electrodes and amplifier/transmitter and use, through amplifier and decoding, for control of BCI; Other Names: Brain Interchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess device specifications for future, larger-scale, application of HD ECoG-BCIs	qualitative description on device specifications and experimental parameters, such as the specific decoder settings, for future, larger scale, application of HD ECoG-BCIs	1 year
Validation of software for independent home-use of advanced BCIs	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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Nick F Ramsey, PhD, UMC Utrecht

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 11, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Quadriplegia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Electrodiagnosis; Electrocorticography
• Other Study ID Numbers: NL-009756; METC nummer 25-211 (Other Identifier: NedMec)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: selected datasets will be available through a public repository after publication of results
• IPD Sharing Time Frame: after first published results, no end date
• IPD Sharing Access Criteria: Publicly available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No