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New treatment option for Locked-in Syndrome
Official title Investigation on the Cortical Communication System
ClinicalTrials.gov ID: NCT06207591
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- 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...
You likely can't join if
- Performance on formal neuropsychological testing that indicates a significant current or recent psychiatric disorder, cognitive or behavioral...
- Medical conditions contraindicating surgery of a chronically implanted device or that could interfere with study participation (for example active...
- Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations too challenging or...
- Inability to undergo MRI for pre-implantation evaluation, for example due to the presence of implanted devices that are incompatible with MRI, which...
- Anticipated need for MRI after implantation of the CortiCom assembly
See the full eligibility 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...
- 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...
- 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
- 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...
- 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...
- 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...
- Anticipated need for MRI after implantation of the CortiCom assembly
The study team makes the final eligibility decision.
Where it's taking place
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.