Martin Schecklmann1, Vahid Nejati2, Timm B Poeppl3, Juliette Peytard4, Rainer Rupprecht4, Thomas C Wetter4, Berthold Langguth4, Peter M Kreuzer4. 1. Department of Psychiatry and Psychotherapy, University of Regensburg, Germany. Electronic address: martin.schecklmann@medbo.de. 2. Department of Psychology, Shahid Beheshti University, Iran. 3. Department of Psychiatry and Psychotherapy, University of Regensburg, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen University, Germany. 4. Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.
Abstract
BACKGROUND:Depressive disorders are linked to dysfunction in prefrontal cortical areas. Hence, non-invasive neurostimulation of the prefrontal cortex has demonstrated antidepressant efficacy. In the present study, we investigated the efficacy of high frequency transcranial random noise stimulation (hf-tRNS) as an add-on treatment for depression in a sham-controlled randomized trial. METHODS:Forty in-patients with depression were randomized and treated with real or sham hf-tRNS (100-650 Hz) with 0 mA offset. The electrodes were mounted over the left and right dorsolateral prefrontal cortex. The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention. Safety parameters included cognitive functioning and reported side-effects. RESULTS: Comparison of real and sham treatment at the planned interim analysis showed an amelioration of symptoms in both groups for all outcomes with numeric but not statistically significant superiority of the sham arm for the primary outcome. Thus, the study was terminated prematurely after an interim analysis. There were no systematic differences with respect to safety parameters. LIMITATIONS: The negative finding might be related to the specific stimulation parameters used in this study. CONCLUSIONS: Our study suggests that prefrontal hf-tRNS is safe but not effective as an add-on treatment of depression. The challenge for future studies employing transcranial electric stimulation remains to identify effective stimulation parameters for the treatment of depression.
RCT Entities:
BACKGROUND:Depressive disorders are linked to dysfunction in prefrontal cortical areas. Hence, non-invasive neurostimulation of the prefrontal cortex has demonstrated antidepressant efficacy. In the present study, we investigated the efficacy of high frequency transcranial random noise stimulation (hf-tRNS) as an add-on treatment for depression in a sham-controlled randomized trial. METHODS: Forty in-patients with depression were randomized and treated with real or sham hf-tRNS (100-650 Hz) with 0 mA offset. The electrodes were mounted over the left and right dorsolateral prefrontal cortex. The Hamilton Depression Rating Scale (primary outcome), the Major Depression Inventory, the Clinical Global Impression scale and the Global Assessment of Functioning scale were used for assessment at baseline, after 3 weeks of intervention (end of treatment), and 9 weeks after intervention. Safety parameters included cognitive functioning and reported side-effects. RESULTS: Comparison of real and sham treatment at the planned interim analysis showed an amelioration of symptoms in both groups for all outcomes with numeric but not statistically significant superiority of the sham arm for the primary outcome. Thus, the study was terminated prematurely after an interim analysis. There were no systematic differences with respect to safety parameters. LIMITATIONS: The negative finding might be related to the specific stimulation parameters used in this study. CONCLUSIONS: Our study suggests that prefrontal hf-tRNS is safe but not effective as an add-on treatment of depression. The challenge for future studies employing transcranial electric stimulation remains to identify effective stimulation parameters for the treatment of depression.
Authors: Andrea Antal; Bruce Luber; Anna-Katharine Brem; Marom Bikson; Andre R Brunoni; Roi Cohen Kadosh; Veljko Dubljević; Shirley Fecteau; Florinda Ferreri; Agnes Flöel; Mark Hallett; Roy H Hamilton; Christoph S Herrmann; Michal Lavidor; Collen Loo; Caroline Lustenberger; Sergio Machado; Carlo Miniussi; Vera Moliadze; Michael A Nitsche; Simone Rossi; Paolo M Rossini; Emiliano Santarnecchi; Margitta Seeck; Gregor Thut; Zsolt Turi; Yoshikazu Ugawa; Ganesan Venkatasubramanian; Nicole Wenderoth; Anna Wexler; Ulf Ziemann; Walter Paulus Journal: Clin Neurophysiol Pract Date: 2022-05-25