Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-24 @ 10:57 PM
NCT ID:
NCT02224469
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02224469
Study Brief:
Protocol Section:
NCT02224469