Kristen Sparrow • April 26, 2023
This study aimed to evaluate the efficacy and safety of TAVNS for migraine, or transcutaneous stimulation of the auricular branch of the vagal nerve (t-VNS) in treating chronic migraine. Patients were randomized to receive either 25 Hz or 1 Hz stimulation for 4 hours a day over three months. Patients in the 1 Hz group had a larger reduction in headache days per 28 days and a higher percentage of patients achieved a 50% or greater reduction in headache days compared to those in the 25 Hz group. HIT-6 and MIDAS scores were significantly improved in both groups, without group differences, and no serious treatment-related adverse events occurred. The study concludes that t-VNS at 1 Hz was safe and effective in treating chronic migraine.
I have used TAVNS in migraine patients in the clinic. I even prepared a presentation for it at the North American Neuromodulation Society conference. So far, I can not say definitively if it improves results over the benefit of acupuncture or not, and whether it further enhances vagal activity over acupuncture’s effect.
NEMOS TAVNS jheadachepain16_63_2015
Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R. Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial. J Headache Pain. 2015;16:543. doi: 10.1186/s10194-015-0543-3. Epub 2015 Jul 9. PMID: 26156114; PMCID: PMC4496420.
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.
Keywords: Sensory nerve; Neuromodulation; Clinical study; Chronic headache; Electrical pulses