Communication through a brain implant for people with locked-in syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to demonstrate the feasibility of a brain-computer interface (BCI) for communication in individuals with locked-in syndrome, a condition where patients are unable to communicate due to severe paralysis. Participants will receive an implant consisting of four high-density electrode grids placed on the brain's surface, allowing for the recording of brain activity associated with attempted hand movements and speech. The study will involve regular visits from researchers for training and data collection over the course of one year, with the potential for extended participation. The goal is to enable participants to use the BCI independently at home, significantly improving their ability to communicate.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18-70 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

Exclusion Criteria:

* 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

Where it's running

• University Medical Center
  Utrecht, Netherlands Recruiting

Study contacts

• Principal investigator: Nick F Ramsey, PhD — UMC Utrecht
• Study coordinator: Mariska J Vansteensel, PhD
• Email: neuroprothese@umcutrecht.nl
• Phone: +31887555121

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.