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

The Journal of Headache and Pain

Research Article

J. Ellrich¹  Andreas Straube²  R. Ruscheweyh²  B. Blum²  O. Eren² 

[1] Department of Health Science and Technology, Professor Dr. med. Jens Ellrich, Aalborg University, Fredrik Bajers Vej 7D2, DK-9220, Aalborg, Denmark;Cerbomed GmbH, Medical Valley Center, Henkestr. 91, 91052, Erlangen, Germany;Klinik und Poliklinik für Neurologie, Oberbayerisches Kopfschmerzzentrum, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany;

关键词: Sensory nerve;    Neuromodulation;    Clinical study;    Chronic headache;    Electrical pulses;   

DOI  :  10.1186/s10194-015-0543-3

 received in 2015-05-05, accepted in 2015-06-16,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundAim 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.MethodsA 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.ResultsOf 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.ConclusionTreatment 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.

【 授权许可】

CC BY   
© Straube et al. 2015. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.