NL-OMON56387
Recruiting
Not Applicable
trecht Neural Prosthesis (UNP) A pilot study on controllability of brain signals and application in locked-in patients - UNP
niversitair Medisch Centrum Utrecht0 sites5 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Zeer ernstige verlamming door trauma of ziekte (Locked in syndroom)
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age 18 \- 75
- •2\) Locked\-in status (i.e. severely paralyzed with communication problems)
- •\- in case of trauma or stroke: at least 1 year after the event
- •\- in case of a neuromuscular disease: slow progression allowed
- •3\) Mentally and physically capable of giving informed consent
- •. If at the time of the informed consent procedure (details in 11\.2\.2\) the
- •patient is not capable to unequivocally communicate consent, earlier
- •expressions of the wish to participate after the patient was given information
- •on the study will suffice.
- •4\) Lives in or close to the Netherlands
Exclusion Criteria
- •1\) Strong and frequent spasms
- •2\) Vital indication for blood thinners
- •3\) Current brain tumor or history of tumor resection
- •4\) Quick medical or neurological deterioration
- •5\) Patients who are considered legally incapable (and who therefore will not be
- •able to give
- •informed consent), unless there is evidence of earlier expressions of the will
- •to participate after information about the study was given to the patient (eg
- •legal document)
- •6\) Current or recent psychiatric disorder
Outcomes
Primary Outcomes
Not specified
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