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Clinical Trials/NL-OMON56387
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Sponsor
niversitair Medisch Centrum Utrecht

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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