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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT01725750
Eligibility Criteria:
Inclusion Criteria:
* Documented TBI of any severity
* At least 6 months post injury
* Presence of clinically significant fatigue, operationalized as a score of 22 or more on the Multidimensional Assessment of Fatigue
* Age 18 or older
* English speaking
Exclusion Criteria:
* Neurological disease other than TBI
* Pregnancy (because of pregnancy fatigue)
* Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure, cirrhosis or cancer treatment in the past year
* Current major depressive episode or substance abuse
* Diagnosed sleep disorder or high risk for sleep apnea
* History of bipolar disorder or manic or hypomanic episodes
* Current chronic, severe headaches
* Sensitivity to bright light
* History of retinal damage or disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01725750
Study Brief:
Protocol Section:
NCT01725750