Status:
COMPLETED
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Lead Sponsor:
UMC Utrecht
Conditions:
Locked-In Syndrome
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completel...
Detailed Description
In this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. For the first time, we will test whether we can record and decode neural s...
Eligibility Criteria
Inclusion
- Age 18 - 75
- 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
- Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech)
- Mentally and physically capable of giving informed consent
- Lives in or close to the Netherlands
- MR compatible
- able to lie flat in the scanner
- no metal objects in or attached to the body
- no claustrophobia
- Visus (largely) intact
- Cognition intact (IQ\>80)
- Compatible with implantation procedure
- good respiratory function or stable respiratory situation using ventilation assistance
Exclusion
- Strong and frequent spasms
- Vital indication for blood thinners
- Current brain tumor or history of tumor resection
- Quick medical or neurological deterioration
- Patients who are considered legally incapable (and who therefore will not be able to give informed consent)
- Current or recent psychiatric disorder
- Catabolic state
- Allergy to the materials of the implant
Key Trial Info
Start Date :
September 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02224469
Start Date
September 9 2015
End Date
February 14 2024
Last Update
December 3 2025
Active Locations (1)
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1
University Medical Center
Utrecht, Netherlands, 3584CX