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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT01306266
Eligibility Criteria:
Inclusion Criteria:
1. U.S. Army soldier with history of concussion while deployed to a combat zone. Concussion is defined as head trauma with all of the following:
2. No loss of consciousness or loss of consciousness less than 30 minutes.
3. Glasgow Coma Score 13-15 (if known)
4. Symptoms or signs of concussion.
5. Concussion was secondary to primary, secondary, or tertiary blast injury.
6. Headaches started within 7 days of concussion.
7. Headaches have occurred for more than 3 months but not more than 24 months since the precipitating concussion.
8. Headaches occurred 3 to 14 days per month during each of the previous two months.
9. Headaches are migraine type and possess three or more of the following migraine features:
10. moderate or severe pain
11. throbbing or pulsatile pain
12. unilateral or asymmetric pain
13. pain exacerbated by or interfering with routine physical activity
14. nausea or vomiting
15. photosensitivity and phonosensitivity
16. Headaches last 4 or more hours without treatment.
17. Males 18 to 49 years of age.
18. Migraine Disability Assessment Score (MIDAS) greater than 10 or Headache Impact Test-6 (HIT6) score greater than 60.
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Exclusion Criteria:
1. Patients with a history of migraine headaches prior to concussion will be excluded.
2. Prior use of any triptan medication for headache.
3. Use of non-opioid analgesic medications 15 or more days per month for the previous month.
4. Use of opioid medications more than 10 days in the previous month.
5. Alcohol consumption of more than two servings (a serving is 2 oz hard liquor, 5 oz wine, or 12 oz beer) per day or more than 3 servings at one time on a weekly basis.
6. Taking two or more medications from the following medication classes: SSRI, SNRI, or TCA.
7. Headache prophylactic medication is allowed but must remain unchanged during the study period.
8. Patients with depression, defined as a PHQ-9 score greater than 15, will be excluded from study participation.
9. PTSD is NOT an exclusion criterion. PTSD will be defined as a clinical diagnosis by a behavioral health provider or PTSD symptom checklist score of 50 or higher.
10. Systolic BP \> 140 or diastolic BP \> 90 on repeated measurements.
11. Active use of dihydroergotamine.
12. Known coronary artery disease, prior myocardial infarction, history of stroke or TIA, or liver disease.
13. Subjects who will not be available for study-related follow-up visits will be excluded.
14. Patient has cognitive impairment defined as mini-mental status exam score less than 27.
15. Patients undergoing a medical board for headache, sequelae of TBI, or psychiatric disorders will be excluded.
16. Patients suspected of malingering, exaggerating symptoms, or non-compliance will be excluded from study participation.
17. Patient has hemiplegic migraine or basilar migraine.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT01306266
Study Brief:
Protocol Section:
NCT01306266