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Updated: Jun 25, 2026
Vagus Nerve Stimulation As an Adjunctive Neurostimulation Tool in Treatment-resistant Depression
Published on: January 7, 2019
Titration of vagus nerve stimulation for difficult-to-treat depression and onset of response: Early insights from the
Erhan Kavakbasi1, Christoph Kraus2, Christine Reif-Leonhard3
1Department of Psychiatry, University Hospital Münster, University of Münster, Münster, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, RWTH Aachen University, Aachen, Germany.
Introduction:
The RESTORE-LIFE study (ClinicalTrials.govNCT03320304) is a global, prospective, multi-center, observational study, which assesses the long-term effectiveness and safety of vagus nerve stimulation (VNS) as an adjunctive treatment in difficult-to-treat depression (DTD). Data on the impact of stimulation parameters on clinical outcome are limited.
Methods:
The study is ongoing, however titration of stimulation parameters and their association with clinical response was analyzed in the first 100 patients (mean age 50.0, range 22-79) reaching 12 months follow-up. Daily charge delivered was compared in 12-month responders vs. non-responders to VNS. Regression models were employed to investigate the relationship between VNS dosing parameters and mean MADRS reduction.
Results:
The probability of reaching an output current of 1.0 mA and 1.5 mA was 93 % and 70 % at 6 months and 95 % and 81 % at 12 months respectively. By month 12, there was a trend towards higher daily charge delivered in non-responders than in responders (p = 0.0798 for median). Older age (>65, p = 0.001) as well as high baseline MADRS (p < 0.001) were significantly predictive for mean MADRS reduction, whereas stimulation parameters at 12 months were not.
Discussion:
The majority of patients reached a current output of at least 1.5 mA, which is considered to be well within the therapeutic range. The daily charge delivered was higher in non-responders, possibly because physicians tended to increase the duty cycle in those who did not respond. Demographics typically associated with difficulty to treat (older age and higher baseline MADRS) were associated with greater MADRS reduction.
