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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02959294
Eligibility Criteria:
Inclusion Criteria:
* Documented history of mTBI or TBI with Correlated MRI or CT
* At least 1 month post mTBI and TBI
* Able and Willing to participate in CT or MRI pre-study and at 3 year, 5 year interval
* Able to provide informed consent to undergo the study
* Depression, Cognitive Disability, Attention Disorders, Headaches or other persistent changes which followed a traumatic brain event (TBI)
* Impaired social or occupational functioning following mTBI or TBI
* History of repetitive events for mTBI and TBI
Exclusion Criteria:
* Documented history of neuro-degenerative illness, seizures, mental illness, or severe medical conditions preceding mTBI or TBI
* Malignances, Bleeding Disorders, Pregnancy or Lactation
* Tumors of Central Nervous System (CNS)
* Lack of adequate donor tissue volume as determined by the primary investigator at their discretion
* Any pre-existing medical condition which, in view of the primary investigator and patient's primary care physician, would prevent participation in study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT02959294
Study Brief:
Protocol Section:
NCT02959294