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 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT05857761
Eligibility Criteria:
Inclusion Criteria:
1. mTBI within the last 2 to 4 months according to the diagnostic criteria recommended by the WHO task force
2. age ≥ 18 years at the time of mTBI
3. Rivermead Post-Concussion Symptoms Questionnaire (RPQ) score ≥ 3 (moderate or severe problem) for subitem headache and a diagnosis of persistent PTH attributed to mTBI according to ICHD-3.
Additionally, for study 2 and 3, subjects have to be stable on preventative headache medication. However, subjects are permitted to take ''as needed'' (PRN) medications throughout the study with documentation in a daily headache diary.
Exclusion Criteria:
1. objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage
2. previous mTBI within the last 2 years years leading to PCS lasting ≥ 3 months. Additionally, for study 2 and 3,
3. Pre-trauma headache frequency ≥ 10 days in average per month the last 3 months prior to mTBI.
4. past history of TMS therapy or TMS-related contraindications (pacemaker, epilepsy etc.).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05857761
Study Brief:
Protocol Section:
NCT05857761