Non-invasive vagus nerve stimulation for treatment of cluster headache: early UK clinical experience

AbstractBackgroundEvidence supports the use of non-invasive vagus nerve stimulation (nVNS; gammaCore ®) as a promising therapeutic option for patients with cluster headache (CH). We conducted this audit of real-world data from patients with CH, the majority of whom were treatment refractory, to explore early UK clinical experience with nVNS used acutely, preventively, or both.MethodsWe retrospectively analysed data from 30 patients with CH (29 chronic, 1 episodic) who submitted individual funding requests for nVNS to the National Health Service. All patients had responded to adjunctive nVNS therapy during an evaluation period (typical duration, 3 –6 months). Data collected from patient interviews, treatment diaries, and physician notes were summarised with descriptive statistics. Pairedt tests were used to examine statistical significance.ResultsThe mean (SD) CH attack frequency decreased from 26.6 (17.1) attacks/wk. before initiation of nVNS therapy to 9.5 (11.0) attacks/wk. (P 
Source: The Journal of Headache and Pain - Category: Neurology Source Type: research

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Purpose of review Cluster headache stands among the worst debilitating pain conditions. Available treatments for cluster headache have often disabling side effects, are not tolerated, or are ineffective. The management of drug-refractory chronic forms is challenging. New treatments are warranted and reported here. Recent findings In cluster headache acute treatment, delivery systems like Demand Valve Oxygen or nonrebreather-type masks could enhance the effectiveness of inhaled oxygen therapy. Noninvasive vagus nerve stimulation relieves cluster headache pain at short-term in episodic patients. Sphenopalatine ganglion ...
Source: Current Opinion in Neurology - Category: Neurology Tags: HEADACHE: Edited by Messoud Ashina and Henrik Winther Schytz Source Type: research
Pain control is one of the biggest challenges facing America today, believes Dr. Peter Staats, co-founder and chief medical officer of electroCore. Chronic pain is an ongoing, debilitating problem for many patients, but for some, overuse of opioid treatments has led to addiction. Such a condition has led to an increasing number of U.S. deaths—one study published in the JAMA Network Open1 found that the percentage of all U.S. deaths attributable to opioids increased 292% between 2001 and 2016. This same study reported that in 2016, 20% of deaths of adults aged 24 to 35 years involve...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news
electroCore, based out of Basking Ridge, New Jersey, received the first FDA clearance for a product to prevent cluster headache. The gammaCore non-invasive vagus nerve stimulation (nVNS) system was previously cleared for treating pain that ...
Source: Medgadget - Category: Medical Devices Authors: Tags: Medicine Neurology Source Type: blogs
Abstract Gulf war illness (GWI) is a chronic multi-symptom disease that afflicts 25-33% of troops that were deployed in the 1990-1991 Gulf War. GWI symptoms include cognitive, behavioral and emotional deficits, as well as migraines and pain. It is possible that exposure to Gulf War agents and prophylactics contributed to the reported symptomology. Pyridostigmine bromide (PB) and permethrin (PER) were given to prevent nerve gas attacks and insect vector born disease, respectively. Previous studies have demonstrated that 10 days of exposure to these chemicals can cause symptoms analogous to those observed in GWI, in...
Source: Neurotoxicology - Category: Neurology Authors: Tags: Neurotoxicology Source Type: research
Abstract Cluster headache is a debilitating disease characterized by excruciatingly painful attacks that affects 0.15% to 0.4% of the US population. Episodic cluster headache manifests as circadian and circannual seasonal bouts of attacks, each lasting 15 to 180 minutes, with periods of remission. In chronic cluster headache, the attacks occur throughout the year with no periods of remission. While existing treatments are effective for some patients, many patients continue to suffer. There are only 2 FDA-approved medications for episodic cluster headache in the United States, while others, such as high-flow oxygen...
Source: The American Journal of Managed Care - Category: Health Management Authors: Tags: Am J Manag Care Source Type: research
Abstract The FDA has cleared gammaCore (non-invasive vagus nerve stimulator [nVNS]) for the treatment of episodic cluster headache (eCH). With the exception of subcutaneous sumatriptan, all other treatments are used off label and have many limitations. The FDA approval process for devices differs from that of drugs. We performed a review of the literature to evaluate new evidence on various aspects of gammaCore treatment and impact. The ACute Treatment of Cluster Headache Studies (ACT1 and ACT2), both double-blind sham-controlled randomized trials, did not meet the primary endpoints of the trials but each demonstr...
Source: The American Journal of Managed Care - Category: Health Management Authors: Tags: Am J Manag Care Source Type: research
Abstract Stimulation of the cervical vagus nerve with implanted vagus nerve stimulation (iVNS) has been used clinically for more than 20 years to treat patients with epilepsy. More recently, a non-invasive cervical vagus nerve stimulation (nVNS), gammaCore, was developed, which has been purported to also stimulate the vagus nerve without the cost and morbidity associated with an iVNS system. gammaCore has been used to acutely treat various types of primary headaches, including migraine and cluster headaches (CH), and for the prevention of episodic, chronic, and menstrual migraines and CH. The gammaCore device was ...
Source: The American Journal of Managed Care - Category: Health Management Authors: Tags: Am J Manag Care Source Type: research
Conclusions:Our initial experience suggests that non-invasive vagus nerve stimulation is an effective treatment for paroxysmal hemicrania and hemicrania continua and may offer an indomethacin-sparing alternative for these conditions.Disclosure: Dr. Tso has nothing to disclose. Dr. Marin has received personal compensation for activities with ElecroCore as a consultant. Dr. Goadsby has received personal compensation for activities with Allergan, eNeura, Autonomic Technologies Inc, Amgen, AlderBio, Pfizer, DrReddy, Zosano, Colucid, Eli Lilly, Avanir, Gore,Heptares, Nupathe, Teva, Cipla, Ajinomoto, Akita,Wells Fargo, Ethicon,P...
Source: Neurology - Category: Neurology Authors: Tags: Headache: Clinical Trials and Therapeutics Source Type: research
AbstractPurpose of ReviewChronic headache sufferers are estimated to be around 3% of the population. These patients have a high disease burden. When prophylactic treatments have low efficacy and tolerability, patients are in need of alternative therapeutic strategies and options.Recent FindingsIn the last decade, a number of neuromodulation procedures have been introduced as treatment of chronic intractable headache patients when pharmacological treatments fail or are not well tolerated. Neurostimulation of peripheral and central nervous system has been carried out, and now, various non-invasive and invasive stimulation de...
Source: Current Pain and Headache Reports - Category: Neurology Source Type: research
AbstractBackgroundIn the PREVention and Acute treatment of chronic cluster headache (PREVA) study, attack frequency reductions from baseline were significantly more pronounced with non-invasive vagus nerve stimulation plus standard of care (nVNS  + SoC) than with SoC alone. Given the intensely painful and frequent nature of chronic cluster headache attacks, additional patient-centric outcomes, including the time to and level of therapeutic response, were evaluated in a post hoc analysis of the PREVA study.FindingsAfter a 2-week baseline phase, 97 patients with chronic cluster headache entered a 4-week randomi...
Source: The Journal of Headache and Pain - Category: Neurology Source Type: research
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