The Gulf War Registry monitors related health conditions of veterans returning from the Persian Gulf Region. Enrollment consists of two phases: Phase I-veterans meet with their local VA Environmental Health Coordinator and complete the self-reported Gulf War Phase I Worksheet (VA Form 10-9009A). Phase II involves a physical exam, medical history review, and laboratory test analysis conducted by a licensed physician. The providers' documentations are frequently referred for exposure assessment and benefit claim. We conducted an initial comparison assessment to ascertain any potential disparity in exposure reporting between the applicants in Phase I and the providers in Phase II.With institutional human subject committee approval, a list of veterans with a Gulf War Registry electronic medical note from the VA San Diego Healthcare System (2013-2015) was obtained. Comparing Phase I with Phase II reports allows three distinct reporting group combinations for each of the 21 exposure categories. Group I: both the patients and the healthcare personnel provided the same report for the respective exposure. Group II: healthcare personnel but not the patients reported the exposure. Group III: only the patients but not the healthcare personnel reported the exposure.A total of 178 (of 367) subjects had both the medical note from the healthcare provider and a physical copy of their Phase I Worksheet available, and therefore were eligible to be included in the overall one-way and subsequent pair-wise chi-square analyses. The results indicate that Group I reporting pattern had a significantly (p < 0.01) lower prevalence in nine exposure categories compared to Group III.The findings suggest that the medical documentation from the healthcare providers does not consistently and accurately reflect the patients' report in near 50% (9/21) of assessed exposure categories. Potential remedies addressing this exposure reporting disparity, such as a standardized template or electronic upload, are further discussed.
Background: Gulf War Illnesses(GWI) is a chronic multisymptomatic illness that includes pain and headaches. Unfortunately, there is no standard treatment available to relieve these debilitating symptoms. Objective: This study compares the effect of active repetitive transcranial magnetic stimulation (rTMS) with sham treatment in reducing GWI-related symptoms. Methods: 40 veterans with GWI were randomized to receive four induction sessions of either active(n=19) or sham(n=21) rTMS at >24 but <72 hours apart and an additional one-month maintenance session at the left motor cortex(10 Hz with 2000 pulses at 80% of resting motor threshold). Pain, headache, GWI-related symptoms and neuropsychological functions were assessed at pre-treatment, post-treatment one-week, one-month, and two-month visits. Results: Mixed effect ANOVA indicated significant 2-factor(TreatmentxVisit) interactions in New Clinical Fibromyalgia Diagnostic Criteria Muscle Widespread Pain Index(NCF-Muscle-WPI)(F=5.706, P=0.022) and Headache Impact Test Concentration(HIT-6-Con) score(F=12.194, P=0.001) with the active group showing significant improvements of HIT-6-Con and NCF-Muscle-WPI scores(±SD) from pre-treatment scores of 10.27(±1.58) and 8.45(±4.65) to post-treatment two-month scores of 8.89(±1.76) and 7.00(±3.85) respectively while the sham group showed no significant or worsening changes. The active group also showed a significant(P<0.02) improvement with Flanders Fatigue Scale score(±SD) at two-month post-treatment visits(from 17.86(±5.91) to 12.11(±5.98)) and trends of improvement in depressive symptoms and daily headache duration, intensity, and level of interference compared to sham. Conclusion: rTMS was shown to reduce GWI related symptoms in this small randomized study. A larger study will be needed to further determine the long-term validity of the treatment for GWI. Conflict of Interests: None to Report. Funding: This work was supported by the Department of Defense Grant W81XWH-16-1-0754.
Abstract Chronic diffuse body pain is unequivocally highly prevalent in Veterans who served in the 1990–91 Persian Gulf War and diagnosed with Gulf War Illness (GWI). Diminished motor cortical excitability, as a measurement of increased resting motor threshold (RMT) with transcranial magnetic stimulation (TMS), is known to be associated with chronic pain conditions. This study compared RMT in Veterans with GWI related diffuse body pain including headache, muscle and joint pain with their military counterparts without GWI related diffuse body pain. Single pulse TMS was administered over the left motor cortex, using anatomical scans of each subject to guide the TMS coil, starting at 25% of maximum stimulator output (MSO) and increasing in steps of 2% until a motor response with a 50 µV peak to peak amplitude, defined as the RMT, was evoked at the contralateral flexor pollicis brevis muscle. RMT was then analyzed using Repeated Measures Analysis of Variance (RM-ANOVA). Veterans with GWI related chronic headaches and body pain (N = 20, all males) had a significantly ( P < 0.001) higher average RMT (% ± SD) of 77.2% ± 16.7% compared to age and gender matched military controls (N = 20, all males), whose average was 55.6% ± 8.8%. Veterans with GWI related diffuse body pain demonstrated a state of diminished corticomotor excitability, suggesting a maladaptive supraspinal pain modulatory state. The impact of this observed supraspinal functional impairment on other GWI related symptoms and the potential use of TMS in rectifying this abnormality and providing relief for pain and co-morbid symptoms requires further investigation. Trial registration : This study was registered on January 25, 2017, on ClinicalTrials.gov with the identifier: NCT03030794. Retrospectively registered. https://clinicaltrials.gov/ct2/show/NCT03030794 .
Abstract Background: Diminished motor cortical excitability, as a measurement of increased resting motor threshold with transcranial magnetic stimulation (TMS), is known to be associated with chronic pain conditions. Over 175,000 veterans who were deployed to the Persian Gulf in 1990-91 suffer from an unexplained multisymptom illness termed Gulf War Illness (GWI) with chronic headaches and diffuse body pain as the most commonly reported symptoms. This study hypothesized that veterans with Gulf War Illness related pain exhibit diminished corticomotor excitability associated with chronic pain states and aimed to assess the resting motor threshold (RMT) at the primary motor cortex (M1) in veterans with GWI.Methods: Single pulse TMS was administered over the left motor cortex, using anatomical scans of each subject to guide the TMS coil, starting at 25% of maximum stimulator output (MSO) and increasing in steps of 2% until a motor response with a 50 µV peak to peak amplitude, defined as the RMT, was evoked at the flexor pollicis brevis muscle. RMT was then analyzed using Repeated Measures Analysis of Variance (RM-ANOVA).Results: Gulf War Veterans (GWV) with chronic headaches and body pain (N=20) had a significantly (P<0.001) higher average resting motor threshold (%± SD) of 77.2%±16.7% compared to age and gender matched GWV Controls (N=20), whose average was 55.6%±8.8%.Conclusion: This study demonstrated that a higher level of stimulation was required to evoke a motor response in veterans with GWI related pain. This diminished corticomotor excitability that suggests a reduced state of supraspinal pain modulatory function. Though further studies will be needed, TMS may provide a means of effectively rectifying this modulatory deficit.
Background Recruitment is the most common failure point for clinical studies, with recruitment failure adversely affecting science, dollar costs, human capital, and the ethical risk–benefit trade-off to study participants. Added problems attend recruitment of special and/or challenging candidate populations, particularly in settings of sparse recruitment resources. Obstacles to study recruitment and participation of ill Gulf War veterans (GWVs) include health barriers, work and family obligations, mistrust of the medical/scientific community, and challenges to identifying/reaching potential participants. Purpose We sought to identify and implement a minimal-cost multipronged recruitment approach for a small single-site (<50 participants) study of a special group, ill GWVs, with approaches substantially applicable to other recruitment settings and larger multisite studies. Methods Categories of recruitment approach included directed as well as general media, collaborations with support groups/interest groups, local free advertising resources (Craigslist and Backpage), physician outreach, Internet-based approaches, and referrals from study participants and screenees. We describe the subcategories and yield of each approach within each approach. Results Each approach contributed candidates to the final recruitment tally, with the largest fractional contribution by directed media (52%). Among the remainder, no other individual approach was clearly dominant (largest contribution: 13%). Limitations Special population subsamples present special challenges; all approaches cited may not be useful in all settings and subpopulations. Conclusions A multipronged suite of minimal-cost approaches led to successful recruitment to target for this single-site clinical trial for a special population with significant recruitment challenges. It additionally yielded a nation-wide corpus of several hundred individuals interested in participation in future studies of GWVs. While certain approaches produced disproportionate yield, it was not possible to predict these a priori. We suggest that this model, which incorporates a suite of approaches, and delineates backup approaches in the event of recruitment shortfall, may provide a template applicable to recruitment of other special samples in settings of limited resources and also is germane to cost-effective recruitment in studies more generally.
Objectives: This study aims to assess (1) the difference in the prevalence of headaches, pain, and other associated symptoms between Gulf War I (1990–1991) and Post-Gulf War I (1992–2015) veterans who served as active military personnel in the Persian Gulf and (2) how the durations of deployment may affect the prevalence of those symptoms. Methods: With institutional human subject committee approval, veterans who were accepted to the Gulf War Registry at the VA San Diego Healthcare System between July 2013 and June 2015 ( N = 367) were included in this retrospective chart review study and grouped according to the Gulf War period they served under or how long they were deployed to the Persian Gulf. Chi-square was used for categorical data analyses and analysis of variance was conducted for continuous outcomes. All analyses were two-tailed, where applicable, with α = 0.05 and Bonferroni for pairwise group comparisons. Results: Veterans who served during Post-Gulf War I or both Gulf War I and Post-Gulf War I exhibited more pain and neurological symptoms than Gulf War I veterans ( p = 0.005, p = 0.003). In addition, veterans who served ⩾12 months reported more overall pain symptoms and analgesic use than those who served less time ( p < 0.001, p = 0.024). Conclusion: The findings suggest that the length of deployment and Persian Gulf deployment period may play a role in acquiring headaches, pain, and other associated symptoms with increased analgesic consumption.
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