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

@entity1 @entity2704 @entity10
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 @entity2704 . METHODS: A monocentric, randomized, controlled, double-blind study was conducted. After one month of baseline, chronic @entity2704 @entity1 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. @entity10 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 @entity10 Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires were used to assess @entity10 . RESULTS: Of 46 randomized @entity1 , 40 finished the study (per protocol). In the per protocol analysis, @entity1 in the 1  Hz group had a significantly larger reduction in @entity10 days per 28  days than @entity1 in the 25  Hz group (-7.0        4.6 vs. -3.3        5.4  days, p   =   0.035). 29.4  % of the @entity1 in the 1  Hz group had a >= 50  % reduction in @entity10 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 @entity2704 by t-VNS at 1  Hz was safe and effective. The mean reduction of @entity10 days after 12  weeks of treatment exceeded that reported for other nerve stimulating procedures.
