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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT05049057
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥18 and ≤50 years of age
* mTBI from any cause including impact, rotational acceleration, blast, or a combination, has occurred within the prior 7 days
* PTH has occurred within the prior 7 days
* Able to provide informed consent
* Likely to stay in the same geographical area for the duration of study
* Has a personal health care provider for standard of care PTH and TBI, including education, diagnostic procedures including neuroimaging and treatment, as deemed clinically indicated by the health care provider
Exclusion Criteria:
* Sustained a moderate or severe TBI, rather than mTBI, indicated with at least 1 of the following associated with head injury:
1. abnormal structural imaging
2. loss of consciousness for \>30 minutes
3. alteration of consciousness/mental state for \>24 hours 3. post-traumatic amnesia for \>1 day
* Participants with ongoing chronic migraine or other chronic daily headache disorders at the time of injury
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05049057
Study Brief:
Protocol Section:
NCT05049057