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:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01640158
Eligibility Criteria:
Inclusion Criteria:
1. Subjects must be 18 - 50 years of age at the time of consent
2. Subjects must have a diagnosis of mTBI
3. Subjects must have persistent cognitive dysfunction confirmed by an objective measure (as recommended by the ICD-10 definition for post-concussion syndrome) or a subjective measure (as recommended by the DSV-IV definition of post-concussional disorder).
4. Subjects must be at least three months out from their most recent TBI, concussion, and/or blast exposure to minimize the effects of spontaneous recovery, as verified through participant interview.
5. Subjects must be fluent English speakers.
6. Subjects must have adequate sensorimotor capacity to perform the program in the judgment of the consenting clinician.
Exclusion Criteria:
1. Subjects must not have a history of penetrating head wounds or a diagnosis of moderate or severe TBI.
2. Subjects must not be in-patients.
3. Subjects must not have a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis).
4. Subjects must not show suicidal ideation as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS).
5. Subjects must now show signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit.
6. Subjects must not have clinically significant visual field deficits noted by the consenting staff member by direct observation or by medical history.
7. Subjects must not be judged to be lacking effort.
8. Subjects must not have problems performing assessments or comprehending or following spoken instructions.
9. Subjects must not be enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01640158
Study Brief:
Protocol Section:
NCT01640158