trecht Neural Prosthesis (UNP) A pilot study on controllability of brain signals and application in locked-in patients - UNP

niversitair Medisch Centrum Utrecht0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•* 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

发起方

niversitair Medisch Centrum Utrecht