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 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT00623506
Eligibility Criteria:
Inclusion Criteria:
1. 18-55 years of age, any ethnic group, either sex
2. History of mild TBI since September 2001. TBI occurring at age 18 or older.
3. We will adhere to the operational definition of mild TBI suggested by the World Health Organization Task Force (Holm et al.2005), with the exception of the Glasgow Coma Scale Score criteria (not available for these participants).
4. Ability to participate fully in the informed consent process.
5. No anticipated need to alter medications for the 10-week duration of the study.
Exclusion Criteria:
1. For this pilot study, we will exclude patients who report a history of seizures.
2. Serious unstable medical illness. History of cerebrovascular accident, prostate, uterine, or breast cancer. Use of oral contraceptives or other hormonal supplementation such as estrogen.
3. Current active suicidal and/or homicidal ideation, intent or plan.
4. Concomitant medications for medical conditions will be addressed on a case-by-case base and determined if exclusionary.
5. Current DSM-IV (Diagnostic and Statistical Manual, Fourth Edition) diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition other than TBI.
6. Female patients who are pregnant or breast-feeding.
7. Known allergy to study medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00623506
Study Brief:
Protocol Section:
NCT00623506