Status:
COMPLETED
Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
University of Arizona
Translational Genomics Research Institute
Conditions:
Post-Traumatic Headache
Eligibility:
All Genders
18-70 years
Brief Summary
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 ...
Detailed Description
The human studies component of this Focused Program include clinical phenotyping, neurophysiology, molecular and genetic biomarker discovery, and brain imaging. This data will be utilized to character...
Eligibility Criteria
Inclusion
- POST-TRAUMATIC HEADACHE ELIGIBILITY CRITERIA
- 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.
Exclusion
- 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)
- Prior brain surgery
- Known brain MRI abnormality that in the investigator's opinion will significantly impact MRI data.
- Sensory disorders that in the investigator's opinion might affect perception of cutaneous thermal stimuli (e.g., peripheral neuropathy) (only for those individuals undergoing pain threshold testing).
- Pregnancy
- Breastfeeding
- Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study.
- HEALTHY CONTROL ELIGIBILITY CRITERIA
- Inclusion Criteria:
- Adults 18-70 years of age.
- Willing and able to return for follow-up visits.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04369729
Start Date
September 9 2020
End Date
August 31 2025
Last Update
September 12 2025
Active Locations (5)
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1
Phoenix VA Health Care System
Phoenix, Arizona, United States, 85012
2
Mayo Clinic
Phoenix, Arizona, United States, 85054
3
Mayo Clinic
Scottsdale, Arizona, United States, 85259
4
Mayo Clinic
Jacksonville, Florida, United States, 32224