scholarly journals EHMTI-0363. Quality of life in subjects treated by non-invasive vagus nerve stimulation using gammacore® for the prevention and acute treatment of chronic cluster headache

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

Non-invasive vagus nerve stimulation significantly improves quality of life in patients with persistent postural-perceptual dizziness

2018 ◽  
Vol 265 (S1) ◽  
pp. 63-69 ◽  
Author(s):  
Ozan E. Eren ◽  
Filipp Filippopulos ◽  
Kristina Sönmez ◽  
Ken Möhwald ◽  
Andreas Straube ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Non Invasive

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.

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