Kinetic oscillation stimulation as treatment of acute migraine: a randomized, controlled pilot study

Abstract

Objective: To assess the relief of migraine pain, especially in the acute phase, by comparing active treatment, ie, kinetic oscillation stimulation (KOS) in the nasal cavity, with placebo.

Background: Exploratory trials testing the efficacy of KOS on migraine patients indicated that this treatment could be a fast-acting remedy for acute migraine pain.

Method: Thirty-six patients were randomized 1:1 using a placebo module to active or placebo treatment in this double-blinded parallel design study. Treatment was administered with a minimally invasive inflatable tip oscillating catheter. Symptom scores (0-10 visual analog scale) were obtained before treatment, every 5 minutes during treatment, at 15 minutes, 2, and 24 hours post-treatment, as well as daily (0-3 migraine pain scale) from 30 days pretreatment until Day 60 post. Thirty-five patients were evaluated (active n=18, placebo n=17). The primary end-point was the change in average pain score from before treatment to 15 minutes after treatment.

Results: Patients who received active treatment reported reduced pain, eg, average visual analog scale pain scores fell from 5.5 before treatment to 1.2 15 minutes after, while the corresponding scores for recipients of placebo fell from 4.9 to 3.9. The changes in pain scores differed between the 2 treatments by 3.3 points (95% confidence interval: 2.3, 4.4), P<.001. Already 5 minutes into the treatment, the difference (1.9 points) was significant (P=.007). The difference was likewise significant at 2 hours post-treatment (3.7 points, P<.001). One patient experienced an adverse event (a vasovagal reaction with full spontaneous recovery) during placebo treatment.

Conclusion: KOS is an effective and safe treatment for acute migraine pain.

Trial registration: ClinicalTrials.gov NCT01880671.

Keywords: autonomic nervous system; kinetic oscillation stimulation; medical device; migraine; minimally invasive; neuromodulation.

© 2014 The Authors. Headache published by Wiley Periodicals, Inc. on behalf of American Headache Society.

Figures

Fig 1

Treatment catheter in plastic bag.

Fig 2

Catheter inserted into nasal cavity and secured with headband.

Fig 3

CONSORT flow diagram.

Fig 4

Individual visual analog scale (VAS) scores by minute during procedure in patients receiving active treatment.

Fig 5

Individual visual analog scale (VAS) scores by minute during procedure in patients receiving placebo treatment.