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:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2025-12-26 @ 12:16 PM
NCT ID:
NCT01123200
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older.
* Presently having difficulty communicating or operating the controls for assistive technology or likely to have difficulty in the next six months.
* Able to see the BCI display
* Able to understand and remember instructions concerning participation.
* Live in an environment that can accommodate the wheelchair portable BCI host computer
* Expected to live in the same physical environment for at least 6 months.
* Has family and caregiver(s) who are supportive of participation in this research.
* Has a primary caregiver who is technically capable, willing to learn the setup and operation of the BCI system, and likely to remain with the subject for at least 6 months.
* Has been shown to be able to use a BCI (in an experimental session under another IRB, e.g. HUM 00012968).
* Has a clear understanding of the shortcomings of the present state of BCI technology
Exclusion Criteria:
* Open head lesions or a history of problems with skin breakdown on the head that may be aggravated by repeated application of electrodes.
* Inability to communicate well enough to give informed consent.
* History of photo-sensitive epilepsy
* Known significant cognitive deficits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01123200
Study Brief:
Protocol Section:
NCT01123200