Charleston, Larry

Abstract Background: There is a need for effective and affordable nondrug therapies for the acute treatment of migraine. Transnasal neuromodulation via evaporative cooling may modulate the sphenopalatine ganglion, which is implicated in migraine. The study aimed to evaluate the safety, tolerability, and optimal dose of this method for acute migraine treatment. Methods: A prospective, randomized, double-blind, multicenter study was conducted at 3 US sites. Subjects received 15 minutes of in-clinic treatment during a migraine attack. Twenty-four subjects were randomized into three groups: 24 liters per minute (LPM), 18 LPM, and 6 LPM. Pain and Most Bothersome Symptom (MBS) were recorded at baseline 2 and 24 hours post treatment. The primary endpoint was pain relief (PR) at 2 hours. Secondaryendpoints included tolerability, MBS relief and pain freedom (PF) at 2 hours and 24 hours Results: Eighty-seven adults with episodic migraine with or without aura were enrolled. PR at 2 hours without rescue medication (woRM) was reported by 89% (8/9) of the participants who received 6LPM. PR at 2 hwoRM was reported to be 56% (5/9) and 50% (3/6) in the 18LPM and 24LPM groups, respectively. PF at 2 hours woRM was reported by 44% (4/9) of participants in the 6LPM group, and no participants in the 18LPM or 24LPM group reported PF at 2 hours. MBS relief at 2 hwas 78% (7/9), 67% (6/9) and 50% (3/6) in the 16, 18 & 24LPM groups, respectively. No adverse events occurred in the 6LPM group,and none were serious or severe in any group. Moderate discomfort was reported by 11% (1/9) of the participants in the 6LPM group. In contrast, 33% (3/9) and 83% ofthe 18LPM and 24LPM groups reported moderate or severe discomfort, respectively. Zero, one, and two subjects discontinued the 15-minute session in the 6LPM, 18LPM, and 24LPM groups, respectively. The study was terminated early because of slow subject accrual. Conclusions: Lower flow rates during transnasal cooling were both effective and tolerable for acute migraine treatment. The study became a dose-ranging trial, with lower flow rates,showing greater efficacy. A future at-home study is planned. Trial Registration: ClinicalTrials.gov Identifier: NCT04936061; Registration date: June 15, 2021. The full study protocol can be accessed at https://clinicaltrials.gov/study/NCT04936061.

Abstract Objective To identify and disseminate research priorities for the headache field that should be areas of research focus during the next 10 years. Background Establishing research priorities helps focus and synergize the work of headache investigators, allowing them to reach the most important research goals more efficiently and completely. Methods The Headache Research Priorities organizing and executive committees and working group chairs led a multistakeholder and international group of experts to develop headache research priorities. The research priorities were developed and reviewed by clinicians, scientists, people with headache, representatives from headache organizations, health‐care industry representatives, and the public. Priorities were revised and finalized after receiving feedback from members of the research priorities working groups and after a public comment period. Results Twenty‐five research priorities across eight categories were identified: human models, animal models, pathophysiology, diagnosis and management, treatment, inequities and disparities, research workforce development, and quality of life. The priorities address research models and methods, development and optimization of outcome measures and endpoints, pain and non‐pain symptoms of primary and secondary headaches, investigations into mechanisms underlying headache attacks and chronification of headache disorders, treatment optimization, research workforce recruitment, development, expansion, and support, and inequities and disparities in the headache field. The priorities are focused enough that they help to guide headache research and broad enough that they are widely applicable to multiple headache types and various research methods. Conclusions These research priorities serve as guidance for headache investigators when planning their research studies and as benchmarks by which the headache field can measure its progress over time. These priorities will need updating as research goals are met and new priorities arise.

The sphenopalatine ganglion (SPG) has attracted the interest of practitioners treating head and face pain for over a century because of its anatomical connections and role in the trigemino‐autonomic reflex. In this review, we discuss the anatomy of the SPG, as well as what is known about its role in the pathophysiology of headache disorders, including cluster headache and migraine. We then address various therapies that target the SPG, including intranasal medication delivery, new SPG blocking catheter devices, neurostimulation, chemical neurolysis, and ablation procedures.

Objective/Background To review the existing literature and describe a standardized methodology by expert consensus for the performance of trigger point injections ( TPIs ) in the treatment of headache disorders. Despite their widespread use, the efficacy, safety, and methodology of TPIs have not been reviewed specifically for headache disorders by expert consensus. Methods The Peripheral Nerve Blocks and Other Interventional Procedures Special Interest Section of the A merican H eadache S ociety over a series of meetings reached a consensus for nomenclature, indications, contraindications, precautions, procedural details, outcomes, and adverse effects for the use of TPIs for headache disorders. A subcommittee of the Section also reviewed the literature. Results Indications for TPIs may include many types of episodic and chronic primary and secondary headache disorders, with the presence of active trigger points ( TPs ) on physical examination. Contraindications may include infection, a local open skull defect, or an anesthetic allergy, and precautions are necessary in the setting of anticoagulant use, pregnancy, and obesity with unclear anatomical landmarks. The most common muscles selected for TPIs include the trapezius, sternocleidomastoid, and temporalis, with bupivacaine and lidocaine the agents used most frequently. Adverse effects are typically mild with careful patient and procedural selection, though pneumothorax and other serious adverse events have been infrequently reported. Conclusions When performed in the appropriate setting and with the proper expertise, TPIs seem to have a role in the adjunctive treatment of the most common headache disorders. We hope our effort to characterize the methodology of TPIs by expert opinion in the context of published data motivates the performance of evidence‐based and standardized treatment protocols.