trecht Neural Prosthesis (UNP) A pilot study on controllability of brain signals and application in locked-in patients
- Conditions
- Zeer ernstige verlamming door trauma of ziekte (Locked in syndroom)Locked-in syndrome
- Registration Number
- NL-OMON56387
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
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
5) MR compatible*
- able to lie flat in the scanner
- no metal objects in or attached to the body
- no claustrophobia
6) Visus (largely) intact
7) Cognition intact (IQ>80)
- In the case of unreliable communication at the time of inclusion, tests of
cognitive functioning will not be conducted and results of fMRI analysis will
inform the neuropsychologist about the patient*s cognitive ability to
understand and follow instructions.
8) Compatible with implantation procedure
- good respiratory function or stable respiratory situation using ventilation
assistance
* Because electrodes are already in place, imaging, electrode placement surgery
and strip selection procedures are not relevant for new participants with
existing implant.
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
7) Catabolic state
8) Allergy to the materials of the implant
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method