Targeted dietary interventions to reduce pain in persistent post-traumatic headache among service members: Protocol for a randomized, controlled parallel-group trial.

INTRODUCTION: Post-traumatic headache (PTH) is common after traumatic brain injury (TBI), especially among active-duty service members (SMs), affecting up to 35% of patients with chronic TBI. Persistent PTH is disabling and frequently unresponsive to treatment and is often migrainous. Here, we describe a trial assessing whether dietary modifications to increase n-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) and reduce n-6 linoleic acid (LA), will alter nociceptive lipid mediators and result in clinical improvements in persistent PTH. METHODS: This prospective, randomized, controlled trial tests the efficacy, safety, and biochemical effects of targeted, controlled alterations in dietary n-3 and n-6 fatty acids in 122 adult SMs and military healthcare beneficiaries with diagnosed TBI associated with actively managed persistent frequent (>8 /month) PTH with migraine. Following a 4-week baseline, participants are randomized to one of two equally intensive dietary regimens for 12 additional weeks: 1) increased n-3 EPA + DHA with low n-6 LA (H3L6); 2) usual US dietary content of n-3 and n-6 fatty acids (Control). During the intervention, participants receive diet arm-specific study oils and foods sufficient for 75% of caloric needs and comprehensive dietary counseling. Participants complete daily headache diaries throughout the intervention. Clinical outcomes, including the Headache Impact Test (HIT-6), headache hours per day, circulating blood fatty acid levels, and bioactive metabolites, are measured pre-randomization and at 6 and 12 weeks. Planned primary analyses include pre-post comparisons of treatment groups on clinical measures using ANCOVA and mixed-effects models. Similar approaches to explore biochemical and exploratory clinical outcomes are planned. CLINICALTRIALS: gov registration: NCT03272399.

An Investigation of the Accuracy of Reaction Time Measurements on ANAM4 TBI-MIL Across Three Computer Platforms.

STUDY DESIGN: Using two observational methods and a within-subjects, counterbalanced design, this study aimed to determine if a computer's hardware and software settings significantly affected reaction time (RT) on the Automated Neuropsychological Assessment Metrics (Version 4) Traumatic Brain Injury Military (ANAM4 TBI-MIL). METHODS: Three computer platforms were investigated: Platform 1-older computers recommended for ANAM4 TBI-MIL administration, Platform 2-newer computers with settings downgraded to run like the older computers, and Platform 3-newer computers with default settings. Two observational methods were used to compare measured RT to observed RT on all three platforms: 1, a high-speed video analysis to compare the timing of stimulus onset and response to the measured RT and 2, comparing a preset RT delivered by a robotic key actuator activated by optic detector to the measured RT. Additionally, healthy active duty service members (n = 169) were administered a brief version of the ANAM4 TBI-MIL battery on each of the three platforms. RESULTS: RT differences were observed with both the high-speed video and robotic arm analyses across all three computer platforms, with the smallest discrepancies between observed and measured RT on Platform 1, followed by Platform 2, then Platform 3. When simple reaction time (SRT) raw and standardized scores obtained from the participants were compared across platforms, statistically significant and clinically meaningful differences were seen, especially between Platforms 1 and 3. CONCLUSIONS: A computer's configurations have a meaningful impact on ANAM SRT scores. The difference in an individual's performance across platforms could be misinterpreted as clinically meaningful change.