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Strategies for Behavioral Research in Neurology: Lessons Learned During the COVID-19 Pandemic and Applications for the Future

Cuneo, Ami Z; Maisha, Kazi; Minen, Mia T
PURPOSE OF REVIEW:Behavioral therapies are proven treatments for many neurologic conditions. However, the COVID-19 pandemic has posed significant challenges for conducting behavioral research. This article aims to (1) highlight the challenges of running behavioral clinical trials during the pandemic, (2) suggest approaches to maximize generalizability of pandemic-era studies, and (3) offer strategies for successful behavioral trials beyond the pandemic. RECENT FINDINGS:Thousands of clinical trials have been impacted by the COVID-19 pandemic, from undergoing protocol revisions to suspension altogether. Furthermore, for ongoing trials, recruitment of diverse populations has suffered, thereby exacerbating existing inequities in clinical research. Patient adherence and retention have been affected by a myriad of pandemic-era restraints, and medical, psychiatric, and other complications from the pandemic have the potential to have long-term effects on pandemic-era study results. In the development of post-pandemic study protocols, attention should be given to designing studies that incorporate successful aspects of pre-pandemic and pandemic-era strategies to (1) broaden recruitment using new techniques, (2) improve access for diverse populations, (3) expand protocols to include virtual and in-person participation, and (4) increase patient adherence and retention.
PMCID:8548698
PMID: 34705122
ISSN: 1534-6293
CID: 5069672

Neuroscience Education as Therapy for Migraine and Overlapping Pain Conditions: A Scoping Review

Minen, Mia T; Kaplan, Kayla; Akter, Sangida; Espinosa-Polanco, Mariana; Guiracocha, Jenny; Khanns, Dennique; Corner, Sarah; Roberts, Timothy
BACKGROUND:Neuroscience education therapy (NET) has been successfully used for numerous overlapping pain conditions, but few studies have investigated NET for migraine. OBJECTIVE:We sought to 1) review the literature on NET used for the treatment of various pain conditions to assess how NET has been studied thus far and 2) recommend considerations for future research of NET for the treatment of migraine. DESIGN/METHODS:Following the PRISMA guideline for scoping reviews, co-author (TR), a medical librarian, searched the MEDLINE, PsychInfo, Embase, and Cochrane Central Clinical Trials Registry databases for peer-reviewed articles describing NET to treat migraine and other chronic pain conditions. Each citation was reviewed by two trained independent reviewers. Conflicts were resolved through consensus. RESULTS:Overall, a NET curriculum consists of the following topics: pain does not equate to injury, pain is generated in the brain, perception, genetics, reward systems, fear, brain plasticity, and placebo/nocebo effects. Delivered through individual, group, or a combination of individual and group sessions, NET treatments often incorporate exercise programs and/or components of other evidence-based behavioral treatments. NET has significantly reduced catastrophizing, kinesiophobia, pain intensity, and disability in overlapping pain conditions. In migraine-specific studies, when implemented together with traditional pharmacological treatments, NET has emerged as a promising therapy by reducing migraine days, pain intensity and duration, and acute medication intake. CONCLUSION:NET is an established treatment for pain conditions, and future research should focus on refining NET for migraine, examining delivery modality, dosage, components of other behavioral therapies to integrate, and migraine-specific NET curricula.
PMID: 34270769
ISSN: 1526-4637
CID: 5039252

Underuse of Behavioral Treatments for Headache: a Narrative Review Examining Societal and Cultural Factors

Langenbahn, Donna; Matsuzawa, Yuka; Lee, Yuen Shan Christine; Fraser, Felicia; Penzien, Donald B; Simon, Naomi M; Lipton, Richard B; Minen, Mia T
Migraine affects over 40 million Americans and is the world's second most disabling condition. As the majority of medical care for migraine occurs in primary care settings, not in neurology nor headache subspecialty practices, healthcare system interventions should focus on primary care. Though there is grade A evidence for behavioral treatment (e.g., biofeedback, cognitive behavioral therapy (CBT), and relaxation techniques) for migraine, these treatments are underutilized. Behavioral treatments may be a valuable alternative to opioids, which remain widely used for migraine, despite the US opioid epidemic and guidelines that recommend against them. Identifying and removing barriers to the use of headache behavioral therapy could help reduce the disability as well as the personal and social costs of migraine. These techniques will have their greatest impact if offered in primary care settings to the lower socioeconomic status groups at greatest risk for migraine. We review the societal and cultural challenges that impose barriers to optimal use of non-pharmacological treatment services. These barriers include insufficient knowledge of migraine/headache behavioral treatments and insufficient availability of clinicians trained in non-pharmacological treatment delivery; limited access in underserved communities; financial burden; and stigma associated with both headache and mental health diagnoses and treatment. For each barrier, we discuss potential approaches to minimizing its effect and thus enhancing non-pharmacological treatment utilization.Case ExampleA 25-year-old graduate student with a prior history of headaches in college is attending school in the evenings while working a full-time job. Now, his headaches have significant nausea and photophobia. They are twice weekly and are disabling enough that he is unable to complete homework assignments. He does not understand why the headaches occur on Saturdays when he pushes through all week to get through his examinations that take place on Friday evenings. He tried two different migraine preventive medications, but neither led to the 50% reduction in headache days his doctor had hoped for. His doctor had suggested cognitive behavioral therapy (CBT) before initiating the medications, but he had been too busy to attend the appointments, and the challenges in finding an in-network provider proved difficult. Now with the worsening headaches, he opted for the CBT and by the fifth week had already noted improvements in his headache frequency and intensity.
PMCID:7849617
PMID: 33527189
ISSN: 1525-1497
CID: 4799612

Headache infusion centers: A survey on treatments provided, infusion center operations, and barriers to developing new infusion centers

Strauss, Lauren Doyle; Yugrakh, Marianna Shnayderman; Kaplan, Kayla E; Minen, Mia T
BACKGROUND:Infusion therapy refers to the intravenous administration of medicines and fluids for the treatment of status migrainosus, severe persistent headaches, or chronic headache. Headache practices and centers offer this treatment for patients as an alternative to the emergency department (ED) setting. However, little information is available in the literature on understanding the operations of an infusion center. OBJECTIVE:We sought to survey the Inpatient Headache & Emergency Medicine specialty section and the Academic Program Directors listserv of the American Headache Society (AHS) to better understand current practices. METHODS:A survey was advertised and distributed to the listservs of both the Inpatient Headache & Emergency Medicine specialty section and the Academic Program Directors, which combined included both academic and private practices. In addition, the survey was available on laptops at related events at an annual AHS meeting in Scottsdale. RESULTS:Of the 127 members of the combined group of both listservs, 50 responded with an overall survey response rate of 39%. Ten out of fifty were from programs with more than one responder completing the survey, leaving 40 unique headache programs. Academic programs made up the majority of programs (85%, 34/40). The total of 40 participating programs is comparable with the 47 academic headache programs listed on the American Migraine Foundation website at the time of the survey. Of the academic programs surveyed, most were hospital based (n = 23) compared with a satellite location (n = 11). Of all programs surveyed, 68% (27/40) offered infusion therapy. Of those that did not have an infusion practice (n = 13), the most common reason cited was insufficient staffing (n = 8). Key highlights of the survey included the following: The majority of programs offering infusions obtain prior authorization before scheduling (70%, 19/27) and offer patient availability 5 days/week (78%, 21/27) typically only during business hours (81%, 22/27). Programs reported that they typically give three to four medications during each infusion session (72%, 18/25). Treatment paradigms varied between programs. Programs surveyed were concentrated in the Northeast and Midwest regions of the United States. CONCLUSION/CONCLUSIONS:The limited number of headache infusion centers overall may contribute to the limited ability of headache infusion centers to prevent ED migraine visits. Headache patients can have unpredictable headache onset, and most of the infusion practices surveyed appeared to adapt to this by offering infusions most days during a work week. However, this need for multiple days per week may also explain the most common reason for not having an infusion practice, which is insufficient staffing. Various treatment paradigms are implemented by different practitioners, and future studies will have to focus on investigation of best practice.
PMID: 34378185
ISSN: 1526-4610
CID: 5006172

Factors Associated With, and Mitigation Strategies for, Healthcare Disparities Faced by Patients With Headache Disorders

Kiarashi, Jessica; VanderPluym, Juliana; Szperka, Christina L; Turner, Scott; Minen, Mia T; Broner, Susan; Ross, Alexandra C; Wagstaff, Amanda E; Anto, Marissa; Marzouk, Maya; Monteith, Teshamae S; Rosen, Noah; Manrriquez, Salvador L; Seng, Elizabeth; Finkel, Alan; Charleston, Larry
OBJECTIVE:To review the contemporary issues of healthcare disparities in Headache Medicine with regard to race/ethnicity, socioeconomic status and geography and propose solutions for addressing these disparities. METHODS:An internet and PubMed search was performed and literature was reviewed for key concepts underpinning disparities in Headache Medicine. Content was refined to areas most salient to our goal of informing the provision of equitable care in headache treatment through discussions with this group of 16 experts from a range of headache subspecialties. RESULTS:Taken together, a multitude of factors including racism, socioeconomic status and insurance status and geographical disparities contribute to the inequities that exist within the healthcare system when treating headache disorders. Interventions such as improving public education, advocacy, optimizing telemedicine, engaging in community outreach to educate primary care providers, training providers in cultural sensitivity and competence and implicit bias, addressing health literacy and developing recruitment strategies to increase representation of underserved groups within headache research are proposed as solutions to ameliorate disparities. CONCLUSION/CONCLUSIONS:Neurologists have a responsibility to provide and deliver equitable care to all. It is important that disparities in the management of headache disorders are identified and addressed.
PMID: 34108270
ISSN: 1526-632x
CID: 4929412

Wearables for Neurologic Conditions: Considerations for Our Patients and Research Limitations

Minen, Mia T; Stieglitz, Eric J
Purpose of Review/UNASSIGNED:In 2019, over 50 million Americans were expected to use wearables at least monthly. The technologies have varied capabilities, with many designed to monitor health conditions. We present a narrative review to raise awareness of wearable technologies that may be relevant to the field of neurology. We also discuss the implications of these wearables for our patients and briefly discuss issues related to researching new wearable technologies. Recent Findings/UNASSIGNED:There are a variety of wearables for neurologic conditions, e.g., stroke (for potential arrhythmia capture), epilepsy, Parkinson disease, and sleep. Research is being performed to capture the risk of neuropsychiatric relapse. However, data are limited and adherence to these wearables is often poorly studied. Summary/UNASSIGNED:The care of neurology patients may ultimately be improved with the use of wearable technologies. More research needs to examine efficacy and implementation strategies.
PMCID:8382408
PMID: 34484952
ISSN: 2163-0402
CID: 5069662

Telehealth as a new care delivery model: The headache provider experience

Minen, Mia T; Szperka, Christina L; Kaplan, Kayla; Ehrlich, Annika; Riggins, Nina; Rizzoli, Paul; Strauss, Lauren Doyle
OBJECTIVE:To assess telehealth practice for headache visits in the United States. BACKGROUND:The rapid roll out of telehealth during the COVID-19 pandemic impacted headache specialists. METHODS:American Headache Society (AHS) members were emailed an anonymous survey (9/9/20-10/12/20) to complete if they had logged ≥2 months or 50+ headache visits via telehealth. RESULTS:Out of 1348 members, 225 (16.7%) responded. Most were female (59.8%; 113/189). Median age was 47 (interquartile range [IQR] 37-57) (N = 154). The majority were MD/DOs (83.7%; 159/190) or NP/PAs (14.7%; 28/190), and most (65.1%; 123/189) were in academia. Years in practice were 0-3: 28; 4-10: 58; 11-20: 42; 20+: 61. Median number of telehealth visits was 120 (IQR 77.5-250) in the prior 3 months. Respondents were "comfortable/very comfortable" treating via telehealth (a) new patient with a chief complaint of headache (median, IQR 4 [3-5]); (b) follow-up for migraine (median, IQR 5 [5-5]); (c) follow-up for secondary headache (median, IQR 4 [3-4]). About half (51.1%; 97/190) offer urgent telehealth. Beyond being unable to perform procedures, top barriers were conducting parts of the neurologic exam (157/189), absence of vital signs (117/189), and socioeconomic/technologic barriers (91/189). Top positive attributes were patient convenience (185/190), reducing patient travel stress (172/190), patient cost reduction (151/190), flexibility with personal matters (128/190), patient comfort at home (114/190), and patient medications nearby (103/190). Only 21.3% (33/155) of providers said telehealth visit length differed from in-person visits, and 55.3% (105/190) believe that the no-show rate improved. On a 1-5 Likert scale, providers were "interested"/"very interested" in digitally prescribing headache apps (median 4, IQR 3-5) and "interested"/"very interested" in remotely monitoring patient symptoms (median 4, IQR 3-5). CONCLUSIONS:Respondents were comfortable treating patients with migraine via telehealth. They note positive attributes for patients and how access may be improved. Technology innovations (remote vital signs, digitally prescribing headache apps) and remote symptom monitoring are areas of interest and warrant future research.
PMID: 34309828
ISSN: 1526-4610
CID: 5004022

Response to Mindfulness-Based Cognitive Therapy Differs Between Chronic and Episodic Migraine

Seng, Elizabeth K; Conway, Alexandra B; Grinberg, Amy S; Patel, Zarine S; Marzouk, Maya; Rosenberg, Lauren; Metts, Christopher; Day, Melissa A; Minen, Mia T; Buse, Dawn C; Lipton, Richard B
Objective/UNASSIGNED:Evaluate whether the benefits of Mindfulness-Based Cognitive Therapy for Migraine (MBCT-M) on headache disability differs among people with episodic and chronic migraine (CM). Methods/UNASSIGNED:This is a planned secondary analysis of a randomized clinical trial. After a 30-day baseline, participants were stratified by episodic (6-14 d/mo) and CM (15-30 d/mo) and randomized to 8 weekly individual sessions of MBCT-M or wait list/treatment as usual (WL/TAU). Primary outcomes (Headache Disability Inventory; Severe Migraine Disability Assessment Scale [scores ≥ 21]) were assessed at months 0, 1, 2, and 4. Mixed models for repeated measures tested moderation with fixed effects of treatment, time, CM, and all interactions. Planned subgroup analyses evaluated treatment*time in episodic and CM. Results/UNASSIGNED:= 0.268). Conclusions/UNASSIGNED:MBCT-M is a promising treatment for reducing headache-related disability, with greater benefits in episodic than CM. Trial Registration Information/UNASSIGNED:ClinicalTrials.gov Identifier: NCT02443519. Classification of Evidence/UNASSIGNED:This study provides Class III evidence that MBCT-M reduces headache disability to a greater extent in people with episodic than CM.
PMCID:8382359
PMID: 34484887
ISSN: 2163-0402
CID: 5069652

Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache

Friedman, Benjamin W; Irizarry, Eddie; Cain, Darnell; Caradonna, Arianna; Minen, Mia T; Solorzano, Clemencia; Zias, Eleftheria; Zybert, David; McGregor, Michael; Bijur, Polly E; Gallagher, E John
OBJECTIVE:To determine whether IV metoclopramide 20 mg + diphenhydramine 25 mg (M + D) was more efficacious than IV placebo for acute moderate or severe posttraumatic headache in the emergency room. METHODS:We conducted this randomized, double-blind, placebo-controlled, parallel-group study in 2 urban emergency departments (EDs). Participants who experienced head trauma and presented to our EDs within 10 days with a headache fulfilling criteria for acute posttraumatic headache were included. We randomized participants in a 1:1 ratio to M + D or placebo. Participants, caregivers, and outcome assessors were blinded to assignment. The primary outcome was improvement in pain on a scale of 0 to 10 between baseline and 1 hour after treatment. RESULTS:= 0.04). CONCLUSION:M + D was more efficacious than placebo with regard to relief of posttraumatic headache in the ED. TRIAL REGISTRATION INFORMATION:ClinicalTrials.gov Identifier: NCT03220958. CLASSIFICATION OF EVIDENCE:This study provides Class I evidence that for patients with acute moderate or severe posttraumatic headache, IV M + D significantly improved pain compared to placebo.
PMCID:8166438
PMID: 33762421
ISSN: 1526-632x
CID: 4924002

Reader Response: Characterizing Opioid Use in a US Population With Migraine: Results From the CaMEO Study [Comment]

Minen, Mia T
PMID: 33820844
ISSN: 1526-632x
CID: 5069642