Review

. 2018 May-Jun;11(3):465-480.

doi: 10.1016/j.brs.2017.12.008. Epub 2017 Dec 29.

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

Marom Bikson¹, Andre R Brunoni², Leigh E Charvet³, Vincent P Clark⁴, Leonardo G Cohen⁵, Zhi-De Deng⁶, Jacek Dmochowski¹, Dylan J Edwards⁷, Flavio Frohlich⁸, Emily S Kappenman⁹, Kelvin O Lim¹⁰, Colleen Loo¹¹, Antonio Mantovani¹², David P McMullen¹³, Lucas C Parra¹, Michele Pearson¹³, Jessica D Richardson¹⁴, Judith M Rumsey¹⁵, Pejman Sehatpour¹⁶, David Sommers¹⁷, Gozde Unal¹, Eric M Wassermann¹⁸, Adam J Woods¹⁹, Sarah H Lisanby¹³

Affiliations

¹ Department of Biomedical Engineering, The City College of the City University of New York, United States.
² Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of Sao Paulo, Sao Paulo, Brazil.
³ Department of Neurology, New York University School of Medicine, New York, NY, United States.
⁴ Department of Psychology, University of New Mexico, Albuquerque, NM, United States.
⁵ Human Cortical Physiology and Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke, Bethesda, MD, United States.
⁶ Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, United States.
⁷ Non-invasive Brain Stimulation and Human Motor Control Laboratory, Burke Rehabilitation and Research, Burke-Cornell Medical Research Facility, White Plains, New York and School of Medicine and Health Sciences, Edith Cowan University, Perth, Australia.
⁸ Department of Psychiatry, Cell Biology and Physiology, Biomedical Engineering, and Neurology, Carolina Center for Neurostimulation, University of North Carolina School of Medicine, Chapel Hill, NC, United States.
⁹ Department of Psychology, San Diego State University, San Diego, CA, United States.
¹⁰ Department of Psychiatry, University of Minnesota, Minneapolis Veterans Administration Health Care System, and Defense Veterans Brain Injury Center, Minneapolis, MN, United States.
¹¹ School of Psychiatry and Black Dog Institute, University of New South Wales, Sydney, Australia.
¹² Department of Physiology, Pharmacology and Neuroscience, City College of the City University of New York, New York, NY, United States.
¹³ Division of Translational Research, National Institute of Mental Health, Bethesda, MD, United States.
¹⁴ Department of Speech and Hearing Sciences, University of New Mexico, Albuquerque, NM, United States.
¹⁵ Division of Translational Research, National Institute of Mental Health, Bethesda, MD, United States. Electronic address: jrumsey@mail.nih.gov.
¹⁶ Department of Psychiatry, Columbia University, New York, NY, United States.
¹⁷ Scientific Review Branch, National Institute of Mental Health, Bethesda, MD, United States.
¹⁸ Behavioral Neurology Unit, National Institute of Neurological Disorders and Stroke, Bethesda, MD, United States.
¹⁹ Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.

PMID: 29398575
PMCID: PMC5997279
DOI: 10.1016/j.brs.2017.12.008

Review

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

Marom Bikson et al. Brain Stimul. 2018 May-Jun.

. 2018 May-Jun;11(3):465-480.

doi: 10.1016/j.brs.2017.12.008. Epub 2017 Dec 29.

Authors

Affiliations

¹ Department of Biomedical Engineering, The City College of the City University of New York, United States.
² Laboratory of Neurosciences (LIM-27), Department and Institute of Psychiatry, University of Sao Paulo, Sao Paulo, Brazil.
³ Department of Neurology, New York University School of Medicine, New York, NY, United States.
⁴ Department of Psychology, University of New Mexico, Albuquerque, NM, United States.
⁵ Human Cortical Physiology and Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke, Bethesda, MD, United States.
⁶ Experimental Therapeutics and Pathophysiology Branch, National Institute of Mental Health, Bethesda, MD, United States.
⁷ Non-invasive Brain Stimulation and Human Motor Control Laboratory, Burke Rehabilitation and Research, Burke-Cornell Medical Research Facility, White Plains, New York and School of Medicine and Health Sciences, Edith Cowan University, Perth, Australia.
⁸ Department of Psychiatry, Cell Biology and Physiology, Biomedical Engineering, and Neurology, Carolina Center for Neurostimulation, University of North Carolina School of Medicine, Chapel Hill, NC, United States.
⁹ Department of Psychology, San Diego State University, San Diego, CA, United States.
¹⁰ Department of Psychiatry, University of Minnesota, Minneapolis Veterans Administration Health Care System, and Defense Veterans Brain Injury Center, Minneapolis, MN, United States.
¹¹ School of Psychiatry and Black Dog Institute, University of New South Wales, Sydney, Australia.
¹² Department of Physiology, Pharmacology and Neuroscience, City College of the City University of New York, New York, NY, United States.
¹³ Division of Translational Research, National Institute of Mental Health, Bethesda, MD, United States.
¹⁴ Department of Speech and Hearing Sciences, University of New Mexico, Albuquerque, NM, United States.
¹⁵ Division of Translational Research, National Institute of Mental Health, Bethesda, MD, United States. Electronic address: jrumsey@mail.nih.gov.
¹⁶ Department of Psychiatry, Columbia University, New York, NY, United States.
¹⁷ Scientific Review Branch, National Institute of Mental Health, Bethesda, MD, United States.
¹⁸ Behavioral Neurology Unit, National Institute of Neurological Disorders and Stroke, Bethesda, MD, United States.
¹⁹ Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, United States.

PMID: 29398575
PMCID: PMC5997279
DOI: 10.1016/j.brs.2017.12.008

Abstract

Background: Neuropsychiatric 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.

Objective: This 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.

Methods: The 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.

Results: Advances 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.

Conclusions: These 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.

Keywords: Neuromodulation; Reproducibility; Transcranial alternating current stimulation (tACS); Transcranial direct current stimulation (tDCS); Transcranial electrical stimulation (tES).

Published by Elsevier Inc.

PubMed Disclaimer

Conflict of interest statement

Financial disclosures

Lucas Parra and Marom Bikson are co-founders of Soterix Medical Inc. and co-inventors in patents held by the City College of New York (CCNY). The goal of these efforts is to make High-Definition tDCS broadly available. Flavio Frohlich is the founder, majority owner, and chief scientific officer of Pulvinar Neuro LLC, which markets devices for tDCS/tACS research. The University of North Carolina has filed several patents based on his inventions. Andre Russowsky Brunoni receives a CAPES-Humboldt research fellowship for experienced researchers. Colleen Loo received tDCS equipment from Soterix for conducting independent, investigator-initiated clinical trials. Zhi-De Deng and Sarah H. Lisanby are co-inventors on TMS technology, unrelated to the topics presented here. Drs. Charvet, Clark, Cohen, Dmochowski, Edwards, Kappen-man, Lim, Mantovani, McMullen, Richardson, Rumsey, Sehatpour, Sommers, Wassermann and Woods, Ms. Unal, and Ms. Pearson report no conflicts.

Figures

**Fig. 1. Common tDCS/tACS montages and corresponding simulated electric field distribution**
A. M1-SO configuration: Sponge electrodes, one over left primary motor cortex, one over the contralateral supraorbital ridge. B. Bilateral dorsolateral prefrontal cortex configuration: Sponge electrodes over the F3 and F4 EEG sites. C. 4 × 1 HD-tDCS M1 configuration: High-definition electrodes, one over M1, four return electrodes surrounding the center electrode. The electric field was simulated with a current amplitude of 1 mA. Electric field simulation was performed using SimNIBS 2.0.1 [191].

See this image and copyright information in PMC

References

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical