Rigor and reproducibility in research with transcranial electrical stimulation: An NIMH-sponsored workshop

Publication date: Available online 29 December 2017
Source:Brain Stimulation
Author(s): Marom Bikson, Andre R. Brunoni, Leigh E. Charvet, Vincent Clark, Leonardo G. Cohen, Zhi-De Deng, Jacek Dmochowski, Dylan Edwards, Flavio Frohlich, Emily Kappenman, Kelvin O. Lim, Colleen Loo, Antonio Mantovani, David McMullen, Lucas C. Parra, Michele Pearson, Jessica D. Richardson, Judith Maureen Rumsey, Pejman Sehatpour, David Sommers, Gozde Unal, Eric M. Wassermann, Adam J. Woods
BackgroundNeuropsychiatric disorders are a leading source of disability and require novel treatments that target mechanisms of disease. As such disorders are thought to result from aberrant neuronal circuit activity, neuromodulation approaches are of increasing interest given their potential for manipulating circuits directly. Low intensity transcranial electrical stimulation (tES) with direct currents (transcranial direct current stimulation, tDCS) or alternating currents (transcranial alternating current stimulation, tACS) represent novel, safe, well-tolerated, and relatively inexpensive putative treatment modalities.ObjectiveThis report seeks to promote the science, technology and effective clinical applications of these modalities, identify research challenges, and suggest approaches for addressing these needs in order to achieve rigorous, reproducible findings that can advance clinical treatment-->.MethodsThe National Institute of Mental Health (NIMH) convened a workshop in September 2016 that brought together experts in basic and human neuroscience, electrical stimulation biophysics and devices, and clinical trial methods to examine the physiological mechanisms underlying tDCS/tACS, technologies and technical strategies for optimizing stimulation protocols, and the state of the science with respect to therapeutic applications and trial designs.ResultsAdvances in understanding mechanisms, methodological and technological improvements (e.g., electronics, computational models to facilitate proper dosing), and improved clinical trial designs are poised to advance rigorous, reproducible therapeutic applications of these techniques. A number of challenges were identified and meeting participants made recommendations made to address them.ConclusionsThese recommendations align with requirements in NIMH funding opportunity announcements to, among other needs, define dosimetry, demonstrate dose/response relationships, implement rigorous blinded trial designs, employ computational modeling, and demonstrate target engagement when testing stimulation-based interventions for the treatment of mental disorders.



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