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

Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R - J Headache Pain (2015)

Bottom Line: HIT-6 and MIDAS scores were significantly improved in both groups, without group differences.There were no serious treatment-related adverse events.Treatment of chronic migraine by t-VNS at 1 Hz was safe and effective.

View Article: PubMed Central - PubMed

Affiliation: Klinik und Poliklinik für Neurologie, Oberbayerisches Kopfschmerzzentrum, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany, Andreas.Straube@med.uni-muenchen.de.

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.

No MeSH data available.


Related in: MedlinePlus

Patient disposition
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Fig3: Patient disposition

Mentions: The study was conducted between March 2012 and July 2014. A total of 46 patients were randomized to the 1 Hz group (n = 22) or the 25 Hz group (n = 24, ITT). 6 patients dropped out during the study. Reasons for dropouts were: adverse events in 4 patients (treatment-related stimulation site ulcer in 3 patients, gastrectomy not related to treatment in 1 patient), insufficient compliance in 1 patient, patient’s request in 1 patient. One additional patient was excluded from the per protocol (PP) analysis after the end of the study because of violation of inclusion criteria (<15 headache days per 28 days in the screening period). This left 17 patients in the 1 Hz group and 22 patients in the 25 Hz group for the PP analysis (Fig. 3) Demographic and headache characteristics of the population are shown in Table 1. There were no significant differences between both groups.Fig. 3


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

Straube A, Ellrich J, Eren O, Blum B, Ruscheweyh R - J Headache Pain (2015)

Patient disposition
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4496420&req=5

Fig3: Patient disposition
Mentions: The study was conducted between March 2012 and July 2014. A total of 46 patients were randomized to the 1 Hz group (n = 22) or the 25 Hz group (n = 24, ITT). 6 patients dropped out during the study. Reasons for dropouts were: adverse events in 4 patients (treatment-related stimulation site ulcer in 3 patients, gastrectomy not related to treatment in 1 patient), insufficient compliance in 1 patient, patient’s request in 1 patient. One additional patient was excluded from the per protocol (PP) analysis after the end of the study because of violation of inclusion criteria (<15 headache days per 28 days in the screening period). This left 17 patients in the 1 Hz group and 22 patients in the 25 Hz group for the PP analysis (Fig. 3) Demographic and headache characteristics of the population are shown in Table 1. There were no significant differences between both groups.Fig. 3

Bottom Line: HIT-6 and MIDAS scores were significantly improved in both groups, without group differences.There were no serious treatment-related adverse events.Treatment of chronic migraine by t-VNS at 1 Hz was safe and effective.

View Article: PubMed Central - PubMed

Affiliation: Klinik und Poliklinik für Neurologie, Oberbayerisches Kopfschmerzzentrum, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany, Andreas.Straube@med.uni-muenchen.de.

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.

No MeSH data available.


Related in: MedlinePlus