First Study With a Brain Implant to Help Locked-in Patients Communicate at Home (NCT02224469) | Clinical Trial Compass
CompletedNot Applicable
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Netherlands6 participantsStarted 2015-09-09
Plain-language 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 completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance