Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache

Completed

Conditions studied: Post-Traumatic Headache

In brief

This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence

Key facts

Study ID

NCT04369729

Run by

Mayo Clinic

People needed

101

Starts

2020-09-09

Expected to finish

2025-08-31

Last updated by the study team

2025-09-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3).
• PTH onset 7-56 days prior to the time of enrollment.
• Adults 18-70 years of age.
• Willing to maintain a headache diary.
• Willing and able to return for follow-up visits.

You may not qualify if…

• Chronic headache (i.e. at least 15 headache days/month for more than 3 months) within 12 months prior to the mTBI that led to the current PTH, including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache.
• Diminished decision-making capacity that in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
• Started or changed dose of a headache preventive medication within the 3 months prior to screening.
• Use of onabotulinumtoxinA in the head, neck or face region within 6 months of screening.
• During the 6 months before screening, use of opioids or barbiturates on at least 4 days per month.
• Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache.
• History of major psychiatric disorder such as schizophrenia and bipolar disorder.
• History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
• History of positive neuroimaging findings that indicate a moderate or severe TBI.
• Contraindications to magnetic resonance imaging, including, but not limited to (only for those individuals participating in the MRI portion of this research):
• Metal implants
• Aneurysm clips
• Severe claustrophobia
• Implanted electronic devices
• Insulin or infusion pump
• Cochlear/otologic/ear implant
• Non-removable prosthesis
• Implanted shunts/catheters
• Certain intrauterine devices
• Tattooed makeup
• Body piercings that cannot be removed
• Metal fragments
• Wire sutures or metal staples
• Factors that reduce MR image quality and interpretability (only for those individuals participating in the MRI portion of this research):
• Dental braces or other non-removable devices (e.g., retainers)

Where it is running

• Phoenix VA Health Care System — Phoenix, Arizona, United States
• Mayo Clinic — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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