scholarly journals EHMTI-0362. Non-invasive vagus nerve stimulation with gammacore® for prevention and acute treatment of chronic cluster headache: report from the extension phase of the preva study

2014 ◽  
Vol 15 (S1) ◽  
Author(s):  
C Gaul ◽  
H Diener ◽  
K Solbach ◽  
N Silver ◽  
A Straube ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Acute Treatment ◽  
Chronic Cluster Headache ◽  
Extension Phase ◽  
Non Invasive

scholarly journals Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study

Cephalalgia ◽  
2017 ◽  
Vol 38 (5) ◽  
pp. 959-969 ◽  
Author(s):  
Peter J Goadsby ◽  
Ilse F de Coo ◽  
Nicholas Silver ◽  
Alok Tyagi ◽  
Fayyaz Ahmed ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Acute Treatment ◽  
Chronic Cluster Headache ◽  
Double Blind ◽  
Non Invasive ◽  
Rescue Treatment ◽  
Full Analysis

Background Clinical observations and results from recent studies support the use of non-invasive vagus nerve stimulation (nVNS) for treating cluster headache (CH) attacks. This study compared nVNS with a sham device for acute treatment in patients with episodic or chronic CH (eCH, cCH). Methods After completing a 1-week run-in period, subjects were randomly assigned (1:1) to receive nVNS or sham therapy during a 2-week double-blind period. The primary efficacy endpoint was the proportion of all treated attacks that achieved pain-free status within 15 minutes after treatment initiation, without rescue treatment. Results The Full Analysis Set comprised 48 nVNS-treated (14 eCH, 34 cCH) and 44 sham-treated (13 eCH, 31 cCH) subjects. For the primary endpoint, nVNS (14%) and sham (12%) treatments were not significantly different for the total cohort. In the eCH subgroup, nVNS (48%) was superior to sham (6%; p < 0.01). No significant differences between nVNS (5%) and sham (13%) were seen in the cCH subgroup. Conclusions Combing both eCH and cCH patients, nVNS was no different to sham. For the treatment of CH attacks, nVNS was superior to sham therapy in eCH but not in cCH. These results confirm and extend previous findings regarding the efficacy, safety, and tolerability of nVNS for the acute treatment of eCH.

scholarly journals Differential efficacy of non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A meta-analysis

Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 967-977 ◽  
Author(s):  
Ilse F de Coo ◽  
Juana CA Marin ◽  
Stephen D Silberstein ◽  
Deborah I Friedman ◽  
Charly Gaul ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Vagus Nerve ◽  
Pain Intensity ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Fixed Effects ◽  
Acute Treatment ◽  
Statistical Power ◽  
Chronic Cluster Headache ◽  
Non Invasive

Background Two randomized, double-blind, sham-controlled trials (ACT1, ACT2) evaluated non-invasive vagus nerve stimulation (nVNS) as acute treatment for cluster headache. We analyzed pooled ACT1/ACT2 data to increase statistical power and gain insight into the differential efficacy of nVNS in episodic and chronic cluster headache. Methods Data extracted from ACT1 and ACT2 were pooled using a fixed-effects model. Main outcome measures were the primary endpoints of each study. This was the proportion of participants whose first treated attack improved from moderate (2), severe (3), or very severe (4) pain intensity to mild (1) or nil (0) for ACT1 and the proportion of treated attacks whose pain intensity improved from 2–4 to 0 for ACT2. Results The pooled population included 225 participants (episodic: n = 112; chronic: n = 113) from ACT1 (n = 133) and ACT2 (n = 92) in the nVNS (n = 108) and sham (n = 117) groups. Interaction was shown between treatment group and cluster headache subtype ( p < 0.05). nVNS was superior to sham in episodic but not chronic cluster headache (both endpoints p < 0.01). Only four patients discontinued the studies due to adverse events. Conclusions nVNS is a well-tolerated and effective acute treatment for episodic cluster headache. Trial registration The studies were registered at clinicaltrials.gov (ACT1: NCT01792817; ACT2: NCT01958125).

scholarly journals Non–Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double‐Blind, Sham‐Controlled ACT1 Study

2016 ◽  
Vol 56 (8) ◽  
pp. 1317-1332 ◽  
Author(s):  
Stephen D. Silberstein ◽  
Laszlo L. Mechtler ◽  
David B. Kudrow ◽  
Anne H. Calhoun ◽  
Candace McClure ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Acute Treatment ◽  
Double Blind ◽  
Non Invasive

scholarly journals Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study

Cephalalgia ◽  
2015 ◽  
Vol 36 (6) ◽  
pp. 534-546 ◽  
Author(s):  
Charly Gaul ◽  
Hans-Christoph Diener ◽  
Nicholas Silver ◽  
Delphine Magis ◽  
Uwe Reuter ◽  
...  
Keyword(s):  
Cluster Headache ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Chronic Cluster Headache ◽  
Controlled Study ◽  
Open Label ◽  
Baseline Phase ◽  
Randomised Study ◽  
Non Invasive

Background Chronic cluster headache (CH) is a debilitating disorder for which few well-controlled studies demonstrate effectiveness of available therapies. Non-invasive vagus nerve stimulation (nVNS) was examined as adjunctive prophylactic treatment of chronic CH. Methods PREVA was a prospective, open-label, randomised study that compared adjunctive prophylactic nVNS ( n = 48) with standard of care (SoC) alone (control ( n = 49)). A two-week baseline phase was followed by a four-week randomised phase (SoC plus nVNS vs control) and a four-week extension phase (SoC plus nVNS). The primary end point was the reduction in the mean number of CH attacks per week. Response rate, abortive medication use and safety/tolerability were also assessed. Results During the randomised phase, individuals in the intent-to-treat population treated with SoC plus nVNS ( n = 45) had a significantly greater reduction in the number of attacks per week vs controls ( n = 48) (−5.9 vs −2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; p = 0.02). Higher ≥50% response rates were also observed with SoC plus nVNS (40% (18/45)) vs controls (8.3% (4/48); p < 0.001). No serious treatment-related adverse events occurred. Conclusion Adjunctive prophylactic nVNS is a well-tolerated novel treatment for chronic CH, offering clinical benefits beyond those with SoC.

Non-invasive vagus nerve stimulation for the management of refractory primary chronic headaches: A real-world experience

Cephalalgia ◽  
2017 ◽  
Vol 38 (7) ◽  
pp. 1276-1285 ◽  
Author(s):  
Michele Trimboli ◽  
Adnan Al-Kaisy ◽  
Anna P Andreou ◽  
Madeleine Murphy ◽  
Giorgio Lambru
Keyword(s):  
Cluster Headache ◽  
Vagus Nerve ◽  
Chronic Migraine ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Chronic Cluster Headache ◽  
Hemicrania Continua ◽  
Primary Headaches ◽  
Non Invasive ◽  
Chronic Headaches

Background Non-invasive vagus nerve stimulation has initial evidence of efficacy in migraine and cluster headache. However, little is known about its role in the management of refractory chronic headaches. Methods We evaluated the preventive and abortive effects of non-invasive vagus nerve stimulation in 41 consecutive patients with refractory primary chronic headaches in an open-label prospective clinical audit. Headache diaries were used to collect clinical information. Those who obtained at least 30% reduction in headache days/episodes after three months of treatment were considered responders and were offered treatment continuation. Results Twenty-three patients with chronic migraine, 12 with chronic cluster headache, four with hemicrania continua and two with short-lasting unilateral neuralgiform headache attacks with autonomic symptoms (SUNA) were treated. Two of 23 chronic migraine patients, one of 12 chronic cluster headache patients, and two of four hemicrania continua patients were considered responders. None of the patients with SUNA benefited from the therapy. Two chronic migraine patients were able to reduce the pain severity of moderate migraines with non-invasive vagus nerve stimulation. Conclusion Non-invasive vagus nerve stimulation may not constitute an effective acute nor preventive treatment in refractory chronic primary headaches. The encouraging effect in hemicrania continua warrants further evaluation in larger studies.

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