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 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 Rationale and design for a randomized, single-center, double-blind, sham-controlled study of non-invasive vagus nerve stimulation for treatment of post-traumatic headache

Neurology ◽  
2019 ◽  
Vol 93 (14 Supplement 1) ◽  
pp. S1.1-S1
Author(s):  
Bert Vargas ◽  
Eric Liebler ◽  
Stephen Bunt ◽  
Charlene Supent-Bell
Keyword(s):  
Vagus Nerve ◽  
Nerve Stimulation ◽  
Vagus Nerve Stimulation ◽  
Acute Treatment ◽  
Preventive Therapy ◽  
Efficacy And Safety ◽  
Headache Disorders ◽  
Double Blind ◽  
Non Invasive ◽  
Post Traumatic

ObjectiveEvaluate the efficacy and safety of non-invasive vagus nerve stimulation (nVNS) for the treatment of post-traumatic headache (PTH).BackgroundWorldwide, ∼69 million people per year sustain a traumatic brain injury (TBI), many of whom develop PTH. Clinicians often treat PTH with drugs approved for primary headache disorders, and many patients self-treat with over-the-counter agents but have inadequate pain relief. There has been little study of therapies for PTH, and safe, effective treatments are needed.Design/MethodsThis randomized, double-blind, sham-controlled, parallel-group pilot study is enrolling adults who present 1–4 weeks after a head injury, meet International Classification of Headache Disorders 3rd edition (ICHD-3) criteria for acute headache attributed to mild TBI, and have ≥2 headaches/week with a migraine or probable migraine phenotype. After a 2-week run-in period, subjects are randomly assigned (1:1 allocation) to receive daily preventive therapy and as-needed acute treatment with nVNS or a sham device. Preventive therapy consists of two 120-second stimulations 3 times daily. Acute treatment comprises 2 stimulations at headache onset and 2 stimulations 20 minutes after the start of initial treatment. Subjects are not to use acute rescue medication for 120 minutes post-treatment. One North American site will enroll ≤80 subjects. The expected duration is 12 months (enrollment, 9 months; participation, 14 weeks).ResultsThe primary effectiveness end point is decrease in pain (on a 7-point scale) 60 minutes post-treatment for all treated headache attacks. Secondary end points include decrease in the frequency of headache days between the run-in period and the last 2 weeks of the double-blind period and responder rates (ie, percentages of subjects with ≥50% decrease in attack frequency). The primary safety end point is the incidence of treatment-related serious adverse events.ConclusionsThis study will assess the efficacy and safety of nVNS as a novel therapy for PTH.

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).

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