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 @ 4:46 AM
Ignite Modification Date:
2025-12-25 @ 4:46 AM
NCT ID:
NCT06901518
Eligibility Criteria:
Inclusion Criteria:
1. Documented history of traumatic brain injury (TBI); acceptable TBI diagnoses could include concussion, SDH, ICH, and/or SAH diagnosed using ICD-10 coding by a medical professional.
2. Frequent post-traumatic headaches with migraine features as defined by the International Classification of Headache Disorders, 3rd Edition (ICHD-3), and this must be documented using ICD-10 coding by a medical professional.
3. Able to consent and participate in this research study.
4. 18 years of age or older.
5. Trial participants may also be using a stable dose of one migraine preventative medication recognized by AHS/AAN as level A or B, for at least 4 months prior to the start of the study screening and start date. Participants should remain on this stable dose throughout the study.
6. Participants who are being treated with OnabotulinumtoxinA and still meet criteria for migraine preventative treatment will be allowed to enroll.
7. Participants may have focal neurologic deficits as a result of suffering a TBI.
8. After review of the headache diary completed during the baseline period, the participant can be classified by the investigator as experiencing either chronic or episodic migraine; Chronic migraine is characterized by the participant having 15 or more headache days, at least 8 of which classify as a migraine. Episodic migraine is characterized by the participant having fewer than 15 headache days per month, and at least 4 of these headache days would classify as migraine.
Exclusion Criteria:
1. Under 18 years of age
2. Participant has a history of migraine headaches, diagnosed via ICD-10 coding and as defined by ICHD-3 criteria, occurring prior to the traumatic brain injury.
3. Participant is not experiencing headaches with migrainous features as defined by the ICHD-3 criteria.
4. Participant is pregnant or lactating or planning on becoming pregnant within the next six months.
5. Participant is unable to give consent to participate.
6. Participant began using unconventional interventions or devices aimed at reducing migraines, like nerve blocks and transcranial magnetic stimulation, within the 2 months prior to study screening.
7. Participant is using opioid or barbiturate therapies on 5 or more days during pre-intervention period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06901518
Study Brief:
Protocol Section:
NCT06901518