Faculty Bibliography

INTRODUCTION/BACKGROUND:Although hand temperature and electromyograph biofeedback have evidence for migraine prevention, to date, no study has evaluated heartrate variability (HRV) biofeedback for migraine. METHODS:2-arm randomized trial comparing an 8-week app-based HRV biofeedback (HeartMath) to waitlist control. Feasibility/acceptability outcomes included number and duration of sessions, satisfaction, barriers and adverse events. Primary clinical outcome was Migraine-Specific Quality of Life Questionnaire (MSQv2). RESULTS:There were 52 participants (26/arm). On average, participants randomized to the Hearthmath group completed 29 sessions (SD = 29, range: 2-86) with an average length of 6:43 min over 36 days (SD = 27, range: 0, 88) before discontinuing. 9/29 reported technology barriers. 43% said that they were likely to recommend Heartmath to others. Average MSQv2 decreases were not significant between the Heartmath and waitlist control (estimate = 0.3, 95% CI = -3.1 - 3.6). High users of Heartmath reported a reduction in MSQv2 at day 30 (-12.3 points, p = 0.010) while low users did not (p = 0.765). DISCUSSION/CONCLUSIONS:App-based HRV biofeedback was feasible and acceptable on a time-limited basis for people with migraine. Changes in the primary clinical outcome did not differ between biofeedback and control; however, high users of the app reported more benefit than low users.

Persistent post-traumatic headache (PPTH) is often the most common injury post mild traumatic brain injury (mTBI), reported by 47%-95% of patients. Progressive muscle relaxation (PMR) has level A evidence in preventing migraine and tension headaches. However, research on this behavioral therapy for PPTH, let alone smartphone-delivered, is limited. We performed a single-arm study of prospective patients calling our Concussion Center between June 2017-July 2018. Inclusion criteria were that subjects had to meet ICHD-3 criteria for PPTH secondary to mTBI, have four or more headache days a month, be age 18-85 and 3-12 months post injury, own a smartphone and not tried headache behavioral therapy within the year. We recorded baseline headache and neuropsychiatric data. Using the RELAXaHEAD smartphone application, which has a headache diary and PMR audio files, participants were instructed to record headache symptoms and practice 20 minutes of PMR daily. There were three monthly follow-up assessments. There were 49 subjects enrolled. Basic demographics were: 33 (67%) female with mean age 40.1±14.6 [20,75]. Of the 49 subjects, 15 (31%) had pre-existing headaches. In 11 (22%) subjects, mTBI was sports-related. Subjects reported 17.7±9.3 [4,31] headache days in the month before enrollment, and 49 (100%) experienced over three concussion symptoms. Participants inputted data in the RELAXaHEAD app on average 18.3±12.0 days [0,31] the first month. Number of participants who did PMR over 4 times/week was 12 (24.5%) the first month, 9 (22.5 %) the second month, and 6 (15%) the third month. After three months, 17 (42.5 %) participants continued doing PMR. Participants cited time constraints, forgetfulness, application glitches and repetitiveness as obstacles to practicing PMR. It is feasible to get PPTH subjects to practice behavioral therapy through low-cost smartphone-based PMR two times weekly. Future work will assess efficacy and examine how to optimize barriers to PMR.

BACKGROUND:Studies suggest that migraine is often underdiagnosed and inadequately treated in the primary care setting, despite many patients relying on their primary care provider (PCP) to manage their migraine. Many women consider their women's healthcare provider to be their PCP, yet very little is known about migraine knowledge and practice patterns in the women's healthcare setting. OBJECTIVE:The objective of this study was to assess women's healthcare providers' knowledge and needs regarding migraine diagnosis and treatment. METHODS:The comprehensive survey assessing migraine knowledge originally developed for PCPs was used in this study, with the addition of a section regarding the use of hormonal medications in patients impacted by migraine. Surveys were distributed online, and primarily descriptive analyses were performed. RESULTS:The online survey was completed by 115 women's healthcare providers (response rate 28.6%; 115/402), who estimated that they serve as PCPs for approximately one-third of their patients. Results suggest that women's healthcare providers generally recognize the prevalence of migraine, but experience some knowledge gaps regarding migraine management. Despite 82.6% (95/115) of survey respondents feeling very comfortable or somewhat comfortable with diagnosing migraine, only 57.9% (66/114) reported routinely asking patients about headaches during annual visits. Very few were familiar with the American Academy of Neurology guidelines on preventative treatment (6.3%; 7/111) and the Choosing Wisely Campaign recommendations on migraine treatment (17.3%; 19/110), and many prescribed medications known to contribute to medication overuse headache. In addition, only 24.3% (28/115) would order imaging for a new type of headache, 35.7% (41/115) for worsening headache, and 47.8% (55/115) for headache with neurologic symptoms; respondents cited greater tendency with sending patients to an emergency department for the same symptoms. Respondents had limited knowledge of evidence-based, non-pharmacological treatments for migraine (i.e., biofeedback or cognitive behavioral therapy), with nearly none placing referrals for these services. Most providers were comfortable prescribing hormonal contraception (mainly progesterone only) to women with migraine without aura (80.9%; 89/110) and with aura (72.5%; 79/109), and followed American College of Obstetricians and Gynecologists (ACOG) guidelines to limit combination hormonal contraception for patients with aura. When queried, 6.3% or less (5/79) of providers would prescribe estrogen-containing contraception for women with migraine with aura. Only 37.3% (41/110) of respondents reported having headache/migraine education. Providers indicated interest in education pertaining to migraine prevention and treatment (96.3%; 105/109), migraine-associated disability (74.3%; 81/109), and diagnostic testing (59.6%; 65/109). CONCLUSION/CONCLUSIONS:Women's healthcare providers appear to have several knowledge gaps regarding the management of migraine in their patients. These providers would likely benefit from access to a headache-specific educational curriculum to improve provider performance and patient outcomes.

OBJECTIVE:Scalable, accessible forms of behavioral therapy for migraine prevention are needed. We assessed the feasibility and acceptability of progressive muscle relaxation (PMR) delivered by a smartphone application (app) in the Primary Care setting. METHODS:This pilot study was a non-blinded, randomized, parallel-arm controlled trial of adults with migraine and 4+ headache days/month. Eligible participants spoke English and owned a smartphone. All participants were given the RELAXaHEAD app which includes an electronic headache diary. Participants were randomized to receive 1 of the 2 versions of the app-one with PMR and the other without PMR. The primary outcomes were measures of feasibility (adherence to the intervention and diary entries during the 90-day interval) and acceptability (satisfaction levels). We conducted exploratory analyses to determine whether there was a change in Migraine Disability Assessment Scale (MIDAS) scores or a change in headache days. RESULTS:Of 139 participants (77 PMR, 62 control), 116 (83%) were female, mean age was 41.7 ± 12.8 years. Most patients 108/139 (78%) had moderate-severe disability. Using a 1-5 Likert scale, participants found the app easy to use (mean 4.2 ± 0.7) and stated that they would be happy to engage in the PMR intervention again (mean 4.3 ± 0.6). For the first 6 weeks, participants practiced PMR 2-4 days/week. Mean per session duration was 11.1 ± 8.3 minutes. Relative to the diary-only group, the PMR group showed a greater non-significant decline in mean MIDAS scores (-8.7 vs -22.7, P = .100) corresponding to a small-moderate mean effect size (Cohen's d = 0.38). CONCLUSION/CONCLUSIONS:Smartphone-delivered PMR may be an acceptable, accessible form of therapy for migraine. Mean effects show a small-moderate mean effect size in disability scores.

OBJECTIVE:Increasingly, patients are seeking same-day care at urgent care (UC) facilities. Little is known about the health care utilization patterns of patients who visit UC facilities for headache and migraine. We examined the frequency of headache and migraine visits and revisits at UC facilities. METHODS:We conducted a retrospective cohort study of headache not otherwise specified (NOS) and migraine visits from 67 NYC UC facilities over an eight-month period. We report descriptive analyses, the frequency of headache NOS revisits, and the elapsed time to revisits. RESULTS:There were 10,240 patients who visited UC facilities for headache NOS or migraine within the eight-month period. The majority of patients, 6,994 (68.3%), were female, and the mean age (SD) was 35.1 (15.0) years. Most (93.9%) patients (N = 9,613) lived within 60 miles of NYC; 5.5% (N = 564) had at least one revisit, and among re-visitors, there was an average (SD) of 2.2 (0.7) visits to UC facilities during the study period and an average time to revisit (SD) of 61.3 (55.2) days. CONCLUSIONS:In just eight months, there were >10,000 headache NOS and migraine visits to UC facilities in NYC, with half of revisits occurring within 90 days. Future work should examine headache management in UC facilities.

PURPOSE OF REVIEW/OBJECTIVE:This narrative review examines the use of behavioral interventions for acute treatment of headache and pain in the emergency department (ED)/urgent care (UC) and inpatient settings. RECENT FINDINGS/RESULTS:Behavioral interventions demonstrate reductions of pain and associated disability in headache, migraine, and other conditions in the outpatient setting. Behavioral treatments may be a useful addition for patients presenting with acute pain to hospitals and emergency departments. We review challenges and limitations and offer suggestions for implementation of behavioral interventions in the acute setting. Some evidence exists for relaxation-based treatments, mindfulness-based treatments, hypnosis/self-hypnosis, and immersive virtual reality for acute pain, migraine, and headache. There are few high-quality studies on behavioral treatments in the inpatient and emergency department settings. Further research is warranted to determine the efficacy and cost-effectiveness of these interventions. Given the general safety and cost-effectiveness of behavioral interventions, healthcare professionals may want to include these therapies in treatment plans.

BACKGROUND:Multiple Sclerosis (MS) and Migraine are comorbid neurologic conditions. Migraine prevalence is three times higher in the MS clinic population compared to the general population, and patients with MS and migraine are more symptomatic than patients with MS without migraine. OBJECTIVE:We sought to conduct a pilot feasibility and acceptability study of the RELAXaHEAD app in MS-Migraine patients and to assess whether there was any change in migraine disability and MS pain-related disability. METHODS:Randomized controlled study of patients with MS-migraine ages 18-80 years with 4+ headache days/ month who were willing to engage in smartphone based behavioral therapy. Half received the RELAXaHEAD app with progressive muscle relaxation (PMR) and the other half received the app without the PMR. Data was collected for 90 days on measures of recruitment, retention, engagement, and adherence to RELAXaHEAD. Preliminary data was also collected on migraine disability (MIDAS) and MS pain (PES). RESULTS:Sixty-two subjects with MS-migraine were enrolled in the study (34 in PMR arm, 28 in monitored usual care arm). On average, during the 90 days, participants played the PMR on average 1.8 times per week, and for 12.9 min on days it was played. Forty-one percent (14/34) of the participants played the PMR two or more times weekly on average. Data was entered into the daily diaries, on average, 49% (44/90) of the days. There were major challenges in reaching subjects in follow-up for the efficacy data, and there was no significant change in migraine disability (MIDAS) scores or MS Pain (PES) scores from baseline to the endpoints. During the six-month follow-up, most patients felt either positively or neutral about the relaxation therapy. CONCLUSION/CONCLUSIONS:There was interest in scalable accessible forms of behavioral therapy to treat migraine and MS-related pain in patients with MS and comorbid migraine. Similar to prior studies, a significant minority were willing to practice the PMR at least twice weekly. In the societal shift from telephone to more text and internet-based interactions, follow up was challenging, but those reached indicated that they appreciated the PMR and would recommend it to others. Future work should focus on engagement and efficacy.

There has been a substantial rise in the number of women pursuing careers in neurology. However, research has shown that women in neurology have high rates of burnout with gender disparities in burnout and attrition in the field. Recently, there was a call from the NIH, including the National Institute of Neurological Disorders and Stroke, asking for input on factors that may limit or discourage grant applications from women. As the recipients of the highly coveted NIH career mentored awards (K awards) in headache medicine, we applaud the NIH for asking for gender-specific feedback and for raising awareness of research showing that female faculty on the Research Track are at an increased risk of departure. Using the NIH model for the Responsible Conduct of Research and the tenant of Nurturing the Fertile Environment, we discuss specific challenges in academic research that may contribute to gender differences in neurology research success. Although the rate of women conducting NIH-funded migraine research increased from 23% to 41% over the last 10 years, more women are currently in training compared with independence, with 6/6 of the NIH training grants but only 12/36 of the NIH research-level grants, held by women in fiscal years 2017-2019. We suggest concrete solutions to these challenges to ensure the success of women in research reaching independence.

BACKGROUND:The development of mobile health (mHealth) technologies is progressing at a faster pace than that of the science to evaluate their validity and efficacy. Under the International Committee of Journal Medical Editors (ICMJE) guidelines, clinical trials that prospectively assign people to interventions should be registered with a database before the initiation of the study. OBJECTIVE:The aim of this study was to better understand the smartphone mHealth trials for high-burden neuropsychiatric conditions registered on ClinicalTrials.gov through November 2018, including the number, types, and characteristics of the studies being conducted; the frequency and timing of any outcome changes; and the reporting of results. METHODS:We conducted a systematic search of ClinicalTrials.gov for the top 10 most disabling neuropsychiatric conditions and prespecified terms related to mHealth. According to the 2016 World Health Organization Global Burden of Disease Study, the top 10 most disabling neuropsychiatric conditions are (1) stroke, (2) migraine, (3) major depressive disorder, (4) Alzheimer disease and other dementias, (5) anxiety disorders, (6) alcohol use disorders, (7) opioid use disorders, (8) epilepsy, (9) schizophrenia, and (10) other mental and substance use disorders. There were no date, location, or status restrictions. RESULTS:Our search identified 135 studies. A total of 28.9% (39/135) of studies evaluated interventions for major depressive disorder, 14.1% (19/135) of studies evaluated interventions for alcohol use disorders, 12.6% (17/135) of studies evaluated interventions for stroke, 11.1% (15/135) of studies evaluated interventions for schizophrenia, 8.1% (11/135) of studies evaluated interventions for anxiety disorders, 8.1% (11/135) of studies evaluated interventions for other mental and substance use disorders, 7.4% (10/135) of studies evaluated interventions for opioid use disorders, 3.7% (5/135) of studies evaluated interventions for Alzheimer disease or other dementias, 3.0% (4/135) of studies evaluated interventions for epilepsy, and 3.0% (4/135) of studies evaluated interventions for migraine. The studies were first registered in 2008; more than half of the studies were registered from 2016 to 2018. A total of 18.5% (25/135) of trials had results reported in some publicly accessible location. Across all the studies, the mean estimated enrollment (reported by the study) was 1078, although the median was only 100. In addition, across all the studies, the actual reported enrollment was lower, with a mean of 249 and a median of 80. Only about a quarter of the studies (35/135, 25.9%) were funded by the National Institutes of Health. CONCLUSIONS:Despite the increasing use of health-based technologies, this analysis of ClinicalTrials.gov suggests that only a few apps for high-burden neuropsychiatric conditions are being clinically evaluated in trials.