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

TY - JOUR

T1 - Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache

T2 - A randomized, double-blind, sham-controlled ACT2 study

AU - Goadsby, Peter J

AU - de Coo, Ilse F

AU - Silver, Nicholas

AU - Tyagi, Alok

AU - Ahmed, Fayyaz

AU - Gaul, Charly

AU - Jensen, Rigmor H

AU - Diener, Hans-Christoph

AU - Solbach, Kasia

AU - Straube, Andreas

AU - Liebler, Eric

AU - Marin, Juana Ca

AU - Ferrari, Michel D

AU - ACT2 Study Group

PY - 2018/4/1

Y1 - 2018/4/1

N2 - 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.

AB - 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.

KW - Acute Disease

KW - Adult

KW - Chronic Disease

KW - Cluster Headache/diagnosis

KW - Double-Blind Method

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Placebos

KW - Prospective Studies

KW - Treatment Outcome

KW - Vagus Nerve Stimulation/methods

U2 - 10.1177/0333102417744362

DO - 10.1177/0333102417744362

M3 - Journal article

C2 - 29231763

SN - 0333-1024

VL - 38

SP - 959

EP - 969

JO - Cephalalgia : an international journal of headache

JF - Cephalalgia : an international journal of headache

IS - 5

ER -