Status:
UNKNOWN
Nutrition for Post-Traumatic Headache
Lead Sponsor:
Uniformed Services University of the Health Sciences
Collaborating Sponsors:
Walter Reed National Military Medical Center
Fort Belvoir Community Hospital
Conditions:
Post-Traumatic Headache Chronic Without Intractable Headache
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this multi-site study is to evaluate the efficacy of a high omega-3/low omega-6 dietary intervention (the H3-L6 Diet) vs. a Control Diet in reducing headache pain and improving function...
Detailed Description
Migraine-like PTH is an ideal patient population to test the effects of the H3-L6 intervention for several reasons. First, although PTH is considered a secondary headache syndrome, the fact that migra...
Eligibility Criteria
Inclusion
- In order to be included in the study, you must be a person of either gender who is at least 18 years of age, meets criteria of having had a traumatic brain injury, a physiological disruption of brain function, as manifested by at least one of the following:
- . Any period of loss of consciousness
- . Any loss of memory for events immediately before or after the accident
- . Any alteration of mental state at the time of the accident (e.g., feeling dazed, disoriented, and confused)
- . Focal neurologic deficits that may or may not be permanent.
- Traumatically induced includes the head being struck, the head striking an object, or the brain undergoing an acceleration/deceleration movement (i.e. whiplash) without direct external trauma to the head.
- Meets Internation Classification of Headache Disorders-version III (ICHD-III) criteria for persistent post-traumatic headache which is defined as a headache of at least 3 months duration caused by a traumatic injury to the head.
- Meets ICHD-III criteria for episodic/chronic migraine, with or without aura (excepting exclusion for organic disease):
- . Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
- . Headache has at least 2 of the following characteristics:
- unilateral location
- pulsating quality
- moderate or severe pain intensity
- aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
- . During headache at least 1 of the following:
- nausea and/or vomiting
- photophobia and phonophobia
- A potential candidate for this study must be under the care of a physician for headaches and have an incomplete response to standard headache treatments.
- Must have headache frequency of more than 8 days per month.
- Must have a headache history of more than 6 months
- Must be able to attend or remotely participate (by video conference or telephone) in seven dietitian counseling sessions, and adhere to diet supplied to study participants.
- Must be a Department of Defense (DoD) healthcare beneficiary and eligible to receive care at Walter Reed National Military Medical Center (WRNMMC), Fort Belvoir Community Hospital (FBCH) or Womack Army Medical Center (WAMC).
Exclusion
- A person cannot be in this study if they have a history of specific food allergies, especially to fish, dairy or gluten.
- Also exclusionary are:
- Pregnancy or anticipated pregnancy
- Aversion to eating fish
- History of organic brain disorder other than TBI (vasculitis, encephalitis, meningitis, brain tumor)
- Major medical illness such as malignancy, diabetes, autoimmune or immune deficiency disorders, history of stroke or myocardial infarction
- Anticipated deployment or move to alternate location in the next 16 weeks
- Inability to read and communicate in English
- Regular use of fatty acid containing supplements
- Active or recent (2 years) history of treatment for substance abuse
- Cognitive impairment that prevents understanding of the protocol and completion of study procedures including compliance with the diet, blood draws and maintaining a daily headache diary.
Key Trial Info
Start Date :
August 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03272399
Start Date
August 21 2017
End Date
March 31 2022
Last Update
October 5 2021
Active Locations (3)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
2
Womack Army Medical Center (WAMC)
Fort Bragg, North Carolina, United States, 28310
3
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States, 22060