NL-OMON53918
Not yet recruiting
Not Applicable
Investigation on the Cortical Communication (CortiCom) System - CortiCom
niversitair Medisch Centrum Utrecht0 sites2 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 2
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18\-70 years
- •Clinical diagnosis of locked\-in state caused by traumatic brain injury,
- •brainstem stroke,
- •neurodegenerative disease, neuromuscular disease or another cause
- •Complete or incomplete tetraplegia (quadriplegia) or tetraparesis
- •(quadriparesis)
- •Motor\-related speech impairment (dysarthria or anarthria)
- •Either receiving tracheostomy invasive ventilation, or having a stable and
- •respiratory situation without respiratory support, allowing for safe
- •intubation, mechanical ventilation and detubation during surgery according to
Exclusion Criteria
- •Performance on formal neuropsychological testing that indicates a significant
- •recent psychiatric disorder, cognitive or behavioral impairment, that would
- •interfere with obtaining informed consent or fully participating in study
- •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
Outcomes
Primary Outcomes
Not specified
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