Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015:16:543.
doi: 10.1186/s10194-015-0543-3. Epub 2015 Jul 9.

Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

Andreas Straube  1 , J Ellrich, O Eren, B Blum, R Ruscheweyh
Affiliations
Randomized Controlled Trial

Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial

Andreas Straube et al. J Headache Pain. 2015.

Abstract

Background: Aim of the study was assessment of efficacy and safety of transcutaneous stimulation of the auricular branch of the vagal nerve (t-VNS) in the treatment of chronic migraine.

Methods: A monocentric, randomized, controlled, double-blind study was conducted. After one month of baseline, chronic migraine patients were randomized to receive 25 Hz or 1 Hz stimulation of the sensory vagal area at the left ear by a handhold battery driven stimulator for 4 h/day during 3 months. Headache days per 28 days were compared between baseline and the last month of treatment and the number of days with acute medication was recorded The Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires were used to assess headache-related disability.

Results: Of 46 randomized patients, 40 finished the study (per protocol). In the per protocol analysis, patients in the 1 Hz group had a significantly larger reduction in headache days per 28 days than patients in the 25 Hz group (-7.0 ± 4.6 vs. -3.3 ± 5.4 days, p = 0.035). 29.4 % of the patients in the 1 Hz group had a ≥50 % reduction in headache days vs. 13.3 % in the 25 Hz group. HIT-6 and MIDAS scores were significantly improved in both groups, without group differences. There were no serious treatment-related adverse events.

Conclusion: Treatment of chronic migraine by t-VNS at 1 Hz was safe and effective. The mean reduction of headache days after 12 weeks of treatment exceeded that reported for other nerve stimulating procedures.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
NEMOS® device and positioning of the electrode for stimulation of the vagus afferents at the concha
Fig. 3
Fig. 3
Patient disposition
Fig. 4
Fig. 4
Mean course of number of headache days per 28 days during t-VNS treatment. Results of the per protocol set are shown (1 Hz: n = 17, 25 Hz: n = 22). Values are mean ± SEM. Mean values are also given in the figure
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Headache Classification Subcommittee of the International Headache Society The International Classification of Headache Disorders, 3rd edition (beta version) Cephalalgia. 2013;33:629–808. doi: 10.1177/0333102413485658. - DOI - PubMed
    1. Bigal ME, Serrano D, Reed M, Lipton RB. Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology. 2008;71:559–566. doi: 10.1212/01.wnl.0000323925.29520.e7. - DOI - PubMed
    1. Dodick DW. Clinical practice. Chronic daily headache. N Engl J Med. 2006;354:158–165. doi: 10.1056/NEJMcp042897. - DOI - PubMed
    1. Lipton RB, Bigal ME. Chronic daily headache: is analgesic overuse a cause or a consequence? Neurology. 2003;61:154–155. doi: 10.1212/WNL.61.2.154. - DOI - PubMed
    1. Diener HC, Dodick DW, Aurora SK, Turkel CC, DeGryse RE, Lipton RB, Silberstein SD, Brin MF. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia. 2010;30:804–814. doi: 10.1177/0333102410364677. - DOI - PubMed

Publication types