Understanding Post-Traumatic Headache: Forward Translation of a Posttraumatic Headache Animal Model to Posttraumatic Headache in the Human
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-010032
Sponsor Protocol Number: 16-010032
About this study
Headache is the most commonly reported symptom after trauma to the head. Although posttraumatic headache (PTH) shares some clinical characteristics with primary headache disorders, such as migraine, there are many unique features including head trauma and the exacerbation of headache with physical and cognitive stressors. The purpose of this study is to determine if subjects who have recently sustained a mild TBI and have PTH will have lower pain thresholds (i.e. hyperalgesia) and greater allodynia compared to healthy controls. The study will also determine if exposure to a bright light stressor will exacerbate hyperalgesia in subjects with mild TBI and PTH while healthy controls will not be affected.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion criteria:
- Male or female adults between the ages of 16-65 years old
- PTH subjects will meet ICHD-3b diagnostic criteria for posttraumatic headache
- Chronic migraine subjects will meet ICHD-3b diagnostic criteria for chronic migraine
- Healthy controls will not meet ICHD-3b diagnostic criteria for posttraumatic headache or migraine
- Subjects will have no contraindication to quantitative sensory testing (QST) or exposure to a high intensity light. For example, no abrasions, open wounds, or active physical injuries on the forehead or ventral medial forearm; no neuropathy.
Exclusion criteria:
- History of ophthalmologic disease
- Use of pain medications 24 hours prior to research testing
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amaal Starling, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available