Non-Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache: Findings From the Randomized, Double-Blind, Sham-Controlled ACT1 Study.

ABSTRACT:

Objective

To evaluate non-invasive vagus nerve stimulation (nVNS) as an acute cluster headache (CH) treatment.

Background

Many patients with CH experience excruciating attacks at a frequency that is not sufficiently addressed by current symptomatic treatments.

Methods

One hundred fifty subjects were enrolled and randomized (1:1) to receive nVNS or sham treatment for ≤1 month during a double-blind phase; completers could enter a 3-month nVNS open-label phase. The primary end point was response rate, defined as the proportion of subjects who achieved pain relief (pain intensity of 0 or 1) at 15 minutes after treatment initiation for the first CH attack without rescue medication use through 60 minutes. Secondary end points included the sustained response rate (15-60 minu

SUBMITTER: Silberstein SD 

PROVIDER: S-EPMC5113831 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature