Post-Traumatic Headache Chronic Without Intractable Headache Clinical Trial
Official title:
Targeted Alteration in Omega-3 and Omega-6 Fatty Acids for Post-traumatic Headache (Nutrition for PTH)
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 in soldiers, veterans and military healthcare beneficiaries with post-traumatic headache (PTH). In addition, the study will examine the effects of the diet interventions on anti-nociceptive and pro-nociceptive lipid mediators derived from omega-3 and omega-6 fatty acids.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | March 31, 2022 |
| Est. primary completion date | March 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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: 1. . Any period of loss of consciousness 2. . Any loss of memory for events immediately before or after the accident 3. . Any alteration of mental state at the time of the accident (e.g., feeling dazed, disoriented, and confused) 4. . 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): 1. . Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated) 2. . Headache has at least 2 of the following characteristics: 1. unilateral location 2. pulsating quality 3. moderate or severe pain intensity 4. aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs) 3. . During headache at least 1 of the following: 1. nausea and/or vomiting 2. 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 Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Walter Reed National Military Medical Center | Bethesda | Maryland |
| United States | Fort Belvoir Community Hospital | Fort Belvoir | Virginia |
| United States | Womack Army Medical Center (WAMC) | Fort Bragg | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Uniformed Services University of the Health Sciences | Fort Belvoir Community Hospital, National Institutes of Health (NIH), University of North Carolina, Chapel Hill, Walter Reed National Military Medical Center, Womack Army Medical Center |
United States,
Ramsden CE, Faurot KR, Zamora D, Palsson OS, MacIntosh BA, Gaylord S, Taha AY, Rapoport SI, Hibbeln JR, Davis JM, Mann JD. Targeted alterations in dietary n-3 and n-6 fatty acids improve life functioning and reduce psychological distress among patients with chronic headache: a secondary analysis of a randomized trial. Pain. 2015 Apr;156(4):587-596. doi: 10.1097/01.j.pain.0000460348.84965.47. — View Citation
Ramsden CE, Faurot KR, Zamora D, Suchindran CM, MacIntosh BA, Gaylord S, Ringel A, Hibbeln JR, Feldstein AE, Mori TA, Barden A, Lynch C, Coble R, Mas E, Palsson O, Barrow DA, Mann DJ. Targeted alteration of dietary n-3 and n-6 fatty acids for the treatment of chronic headaches: a randomized trial. Pain. 2013 Nov;154(11):2441-2451. doi: 10.1016/j.pain.2013.07.028. Epub 2013 Jul 22. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Primary Clinical Outcome: To compare the efficacy of the high omega-3/low omega-6 (H3-L6) diet to the low omega-3/high omega-6 (L3-H6) diet in reducing headache pain and improving headache-related quality of life. | Up to 300 participants complete the Headache Impact Test (HIT-6)-a headache-specific quality of life measure 6 times while enrolled in the study. The primary outcome measure is the change in the HIT-6 scores at baseline and at the end of the diet intervention. | The HIT-6 is administered at study visits at week 0 (enrollment), 4, 10, 12, 14, 16 | |
| Primary | Primary Biochemical Outcome: To evaluate the effects of the H3-L6 and L3-H6 Diet on circulating fatty acids and bioactive metabolites. | All study participants will have blood drawn 3 times during the 16-week study for analysis of circulating fatty acids and their bioactive metabolites. The following fatty acids will be measured in each blood sample (ng or pg per mL): 17-hydroxy-DHA (docosahexaenoic acid), 18-Hydroxy-EPA (eicosapentaenoic acid), 9-HODE (hydroxyl-octadecadienoic acid), 13-ODE (octadecadienoic acid), 5-HETE (hydroxyl-eicosatetraenoic acid), 8-HETE, 9-HETE, 11-HETE. Changes in 17-hydroxy-DHA and related fatty acids levels between blood draws at baseline and at the end of the 12-week diet intervention will be compared with changes in headache frequency and severity at the same time points. | Fasting blood draws at study visits at weeks 4, 10, 16 | |
| Secondary | To compare the efficacy of the high omega-3/low omega-6 (H3-L6) diet to the low omega-3/high omega-6 (L3-H6) diet in reducing headache pain. | Up to 300 participants complete a headache diary daily while enrolled in the 16-week study. Participants record the total number of headache hours per day. The outcome measure is the change in the mean daily headache hours at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups. | Daily on-line diary entry during the 16-week study | |
| Secondary | To explore the potential of the H3-L6 intervention for improving non-headache pain outcomes. | Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in non-headache pain. A survey of pain, the Total Body Pain Scale, will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a reduction in non-headache pain as measured by the survey at baseline and at the end of the diet intervention. | Study visits at week 0 and 16 | |
| Secondary | To explore the potential of the H3-L6 intervention for decreasing acute pain medication usage | Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in: Use of acute pain medications. Participants will daily record all pain medications used in that 24-hour period. The outcome measure is the change in the acute pain medications sued at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups. | Daily on-line diary entry during the 16-week study | |
| Secondary | To explore the potential of the H3-L6 intervention for improving sleep quality | Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in sleep quality. A sleep quality survey, the PSQI, will be administered at baseline at and the end of the 12-week diet intervention. The outcome measure is the change in the PSQI score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups. | the PSQI is administered at weeks 4 and 16 of the study | |
| Secondary | To explore the potential of the H3-L6 intervention for improving psychological distress (depression/anxiety) | The PROMIS-29, a survey of psychological distress (depression/anxiety), will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a reduction in depression and/or anxiety as measured by the PROMIS-29 at baseline and at the end of the diet intervention. | Study visits at week 0 and 16 | |
| Secondary | To explore the potential of the H3-L6 intervention for improving symptoms of post-traumatic stress disorder (PTSD) | Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in symptoms of post-traumatic stress disorder (PTSD). The PCL-C, a survey of post-traumatic stress symptoms, will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is the reduction in the PCL-C score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups. | The PCL-C is administered at study visits at weeks 4 &16 | |
| Secondary | To explore the potential of the H3-L6 intervention for improving post-concussive symptoms. | Compared to the Control Diet, the H3-L6 Diet may produce significant improvement in post-concussive symptoms. The Neurobehavioral Symptom Inventory (NSI) and the Glasgow Outcome Score-Extended (GOS-E) will be administered at baseline and at the end of the 12-week diet intervention. The outcome measure is a change in the NSI and GOS-E score at baseline and at the end of the diet intervention between the H3-L6 and L3-H6 diet intervention groups. | NSI and GOS-E are administered at weeks 4 and 16. |