Non-invasive vagus nerve stimulation for prevention of migraine: The multicenter, randomized, double-blind, sham-controlled PREMIUM II trial.

Aim: Evaluate the efficacy and safety of non-invasive vagus nerve stimulation for migraine prevention.

Methods: After completing a 4-week diary run-in period, adults who had migraine with or without aura were randomly assigned to receive active non-invasive vagus nerve stimulation or sham therapy during a 12-week double-blind period.

Results: Of 336 enrolled participants, 113 (active, n = 56; sham, n = 57) completed ≥70 days of the double-blind period and were ≥66% adherent with treatment, comprising the prespecified modified intention-to-treat population.

Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study.

Objective: To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.

Background: Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.

Methods: One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase.

Safety and efficacy of AMG 334 for prevention of episodic migraine: a randomised, double-blind, placebo-controlled, phase 2 trial.

Background: The calcitonin gene-related peptide (CGRP) pathway is a promising target for preventive therapies in patients with migraine. We assessed the safety and efficacy of AMG 334, a fully human monoclonal antibody against the CGRP receptor, for migraine prevention.

Methods: In this multicentre, randomised, double-blind, placebo-controlled, phase 2 trial, patients aged 18-60 years with 4 to 14 migraine days per month were enrolled at 59 headache and clinical research centres in North America and Europe, and randomly assigned in a 3:2:2:2 ratio to monthly subcutaneous placebo, AMG 334 7 mg, AMG 334 21 mg, or AMG 334 70 mg using a sponsor-generated randomisation sequence centrally executed by an interactive voice response or interactive web response system.

Acupuncture for migraine prevention.

Background: Migraine is a complex and multifactorial brain disorder affecting approximately 18% of women and 5% of men in the United States, costing billions of dollars annually in direct and indirect healthcare costs and school and work absenteeism and presenteeism. Until this date, there have been no medications that were designed with the specific purpose to decrease the number of migraine attacks, which prompts a search for alternative interventions that could be valuable, such as acupuncture.

Methods: Acupuncture origins from ancient China and encompasses procedures that basically involve stimulation of anatomical points of the body.

Occipital nerve stimulation for the treatment of intractable chronic migraine headache: ONSTIM feasibility study.

Background: Medically intractable chronic migraine (CM) is a disabling illness characterized by headache ≥15 days per month.

Methods: A multicenter, randomized, blinded, controlled feasibility study was conducted to obtain preliminary safety and efficacy data on occipital nerve stimulation (ONS) in CM. Eligible subjects received an occipital nerve block, and responders were randomized to adjustable stimulation (AS), preset stimulation (PS) or medical management (MM) groups.

Can indomethacin act as a disease modifying agent in hemicrania continua? A supportive clinical case.

The natural history of hemicrania continua (HC) is not well-known. Most sufferers have the unremitting form and thus may have a lifetime duration of pain. There are only very rare cases in the literature documenting HC remission after treatment of the unremitting form with indomethacin.

Trigeminal autonomic cephalalgias.

The trigeminal autonomic cephalalgias (TACs) are a group of primary headache syndromes all marked by headache and associated autonomic features. The TACs include cluster headache, paroxysmal hemicrania, hemicrania continua, and short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing syndrome. Diagnosis is made after looking at headache frequency, duration, and accompanying symptoms.

Comprehensive inpatient treatment of refractory chronic daily headache.

Objective: (1) To assess outcome at discharge for a consecutive series of admissions to a comprehensive, multidisciplinary inpatient headache unit; (2) To identify outcome predictors.

Background: An evidence-based assessment (2004) concluded that many refractory headache patients appear to benefit from inpatient treatment, underscoring the need for more research, including outcome predictors.

Methods: The authors completed a retrospective chart review of 283 consecutive admissions over 6 months.

Pearls from an inpatient headache unit.

Much can be learned from treating over 15,000 headache hospitalized patients over the course of 30 years. By the very need to be admitted, these individuals are complicated, both physiologically and often psychologically. Founded in 1978, the Michigan Head Pain and Neurological Institute and its hospital unit developed a set of criteria for admission and a growing staff of professionals to serve this complex population of patients.

Headache and behavioral medicine: a 50-year retrospective.

This article reviews all behaviorally oriented articles published in Headache from 1961(1:1) through the first 3 issues of 2008 and provides an analysis of trends in categories of articles by decade. A mean of 21.6% of all articles included significant attention to behavioral variables; this percentage was relatively stable from 1980 through 2008.

Trendelenburg position: a tool to screen for the presence of a low CSF pressure syndrome in daily headache patients.

Objective: To test the hypothesis that the Trendelenburg position is an accurate screening investigation for the presence of a low cerebrospinal fluid (CSF) pressure syndrome in patients with daily headache.

Background: The Trendelenburg position causes a rapid increase in intracranial CSF pressure. In a patient with a known CSF leak who overtime had less improvement in the supine position, being placed in Trendelenburg rapidly alleviated her daily headache.

Screening and behavioral management: medication overuse headache--the complex case.

The new appendix criteria for a broader concept of chronic migraine from the International Headache Society no longer require headache resolution or return to the previous headache pattern to confirm the diagnosis of medication overuse headache (MOH). MOH can be subdivided into simple (Type I) and complex (Type II). Complex cases may involve long-term use of daily opioids or combination analgesics, multisourcing, multiple psychiatric comorbidities, and/or a history of relapse.

Clomiphene citrate for treatment refractory chronic cluster headache.

A treatment refractory chronic cluster headache patient is presented who became cluster-free on clomiphene citrate. The author has previously reported a SUNCT patient responding to clomiphene citrate. Hypothalamic hormonal modulation therapy with clomiphene citrate may become a new preventive choice for trigeminal autonomic cephalalgias.

Pure menstrual cluster headache.

The influence of the menstrual cycle on female cluster headache is not well documented in the literature. A case patient is presented who had cluster headaches only during her menstrual cycles. This appears to be the first ever reported case of pure menstrual cluster headache.

Elevation of CSF tumor necrosis factor alpha levels in new daily persistent headache and treatment refractory chronic migraine.

Objective: To determine if patients with new daily persistent headache (NDPH) have elevated levels of tumor necrosis factor alpha (TNF alpha) in the CSF.

Background: NDPH is considered one of the most treatment resistant of all headache syndromes. This reflects a lack of understanding of its pathogenesis.

Vanishing cerebellar infarcts in a migraine patient.

Recent population-based studies have suggested that migraine is a risk factor for the development of infarct-like lesions in the territory of the posterior circulation. These lesions are thought to be true vascular infarcts based on their size, location and magnetic resonance imaging (MRI) characteristics. However, as there are no postmortem studies identifying the pathology of these MRI findings, their true aetiology is unknown.

Acute treatment for migraine headache.

Migraine headaches can be frequent and disabling. Effective acute treatment can improve the quality of life for migraineurs. The migraine attack is made up of phases, which include the prodrome, aura and the headache itself.

Staging headache cases: reconciling the complexity of a case with the required intensity of treatment.

To stage a chronic illness is to place the case along a continuum of illness progression and complexity. Staging can also identify key clinical variables and treatment targets in order to assure the most effective treatment, as well as providing the basis for measuring illness progression and improvement. Underlying an effective staging concept is the principle that to achieve clinically effective outcomes and maximal cost effectiveness, the severity and complexity of a case must be matched to the most appropriate level and intensity of care.

DHE in the pharmacotherapy of migraine: potential for a larger role.

Despite a large array of currently marketed, frequently effective drugs for the acute treatment of migraine headache, comprising various classes and formulations, predictably reliable treatment for most headache types is often lacking. Dihydroergotamine mesylate (DHE) is a comparatively safe and effective therapy for migraine headache that could potentially be used for a broader range of headache types than occurs at present. The features of DHE supporting this assertion include (1) effectiveness in terminating severe, long-lasting headaches, (2) rapid onset of action, (3) very low rates of headache recurrence, (4) minimal risk of medication-overuse headache, and (5) in the nasal spray formulation, suitability for outpatients (especially patients who are very nauseated or vomiting, potentially obviating the need for an office or hospital visit for acute care).

Pharmacology of dihydroergotamine and evidence for efficacy and safety in migraine.

Dihydroergotamine mesylate (DHE), an ergot alkaloid, has been extensively utilized and studied in the treatment of episodic and chronic migraine. This article reviews the pharmacokinetics, pharmacodynamics, and clinical efficacy and safety of DHE, particularly in comparison to ergotamine tartrate (ET), a similar ergot alkaloid with a long history of use in the treatment of migraine. Structural differences between these 2 compounds account for clinically important distinctions in their pharmacokinetic, pharmacodynamic, and adverse event profiles.

Medication overuse headache: biobehavioral issues and solutions.

This article reviews current research on medication-overuse headache (MOH), and provides clinical suggestions for effective treatment programs. Epidemiological research has identified reliance on analgesics as a predictive factor in headache chronicity. MOH can be distinguished as simple (Type I) or complex (Type II).