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Focal Electrical Stimulation as an Effective Sham Control for Active rTMS and Biofeedback Treatments

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Abstract

A valid sham control is important for determining the efficacy and effectiveness of repetitive transcranial magnetic stimulation (rTMS) as an experimental and clinical tool. Given the manner in which rTMS is applied, separately or in combination with self-regulatory approaches, and its intended impact on brain states, a valid sham control of this type may well serve as a meaningful control for biofeedback studies, where efforts to develop a credible control have often been less than ideal. This study examined the effectiveness of focal electrical stimulation of the frontalis muscle as a sham technique for blinding participants to high-frequency rTMS over the dorso-lateral prefrontal cortex (DLPFC) at durations, intensities, and schedules of stimulation similar to many clinical applications. In this within-subjects single blind design, 19 participants made guesses immediately after receiving 54 counterbalanced rTMS sessions (sham, 10 Hz, 20 Hz); 7 (13 %) of the guesses were made for sham, 31 (57 %) were made for 10 Hz, and 16 (30 %) were made for 20 Hz. Participants correctly guessed the sham condition 6 % (CI 1, 32 %) of the time, which is less than the odds of chance (i.e., of guessing at random, 33 %); correctly guessed the 10 Hz condition 66 % (CI 43, 84 %) of the time, which was greater than chance; and correctly guessed the 20 Hz condition 41 % (CI 21, 65 %) of the time, which was no different than chance. Focal electrical stimulation therefore can be an effective sham control for high-frequency rTMS of the DLPFC, as well as for active biofeedback interventions. Participants were unaware that electrical stimulation was, in fact, sham rTMS.

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Acknowledgments

This research is supported by an award from the National Center for Research Resources (P20 RR020146, UL1RR029884) and the National Institute of Child Health and Human Development (HD055677, HD055269).

Conflict of interest

Dr. Sheffer has received research funding from Pfizer, Inc. Dr. Bickel is a principal in HealthSIm LLC. Drs. Mennemeier, Dornhoffer, and Kimbrell, and Ms. Brackman, Brown, and Vuong, and Mr. Chellette reported no biomedical financial interests or potential conflicts of interest.

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Authors and Affiliations

  1. Department of Health Behavior and Health Education, University of Arkansas for Medical Sciences, Little Rock, AR, USA

    Christine E. Sheffer, Sharon Brackman & Mai Vuong

  2. Department of Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA

    Mark S. Mennemeier & Ginger Brown

  3. Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA

    Reid D. Landes

  4. Department of Otolaryngology—Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA

    John Dornhoffer

  5. Mental Health Service Central Arkansas Veterans Healthcare System, Little Rock, AR, USA

    Timothy Kimbrell

  6. Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, USA

    Timothy Kimbrell

  7. Advanced Recovery Research Center, Virginia Tech Carilion Research Institute, Roanoke, VA, USA

    Warren K. Bickel

  8. Department of Physical Medicine and Rehabilitation, University of Kentucky, Louisville, KY, USA

    Kenneth C. Chelette

  9. Sophie Davis School of Biomedical Education, City College of New York, Townsend Harris Hall Suite 400, 160 Convent Ave, New York, NY, 10031, USA

    Christine E. Sheffer

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  1. Christine E. Sheffer
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  2. Mark S. Mennemeier
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  3. Reid D. Landes
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  4. John Dornhoffer
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  7. Sharon Brackman
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  8. Kenneth C. Chelette
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  9. Ginger Brown
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  10. Mai Vuong
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Correspondence to Christine E. Sheffer.

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Sheffer, C.E., Mennemeier, M.S., Landes, R.D. et al. Focal Electrical Stimulation as an Effective Sham Control for Active rTMS and Biofeedback Treatments. Appl Psychophysiol Biofeedback 38, 171–176 (2013). https://doi.org/10.1007/s10484-013-9221-x

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  • DOI: https://doi.org/10.1007/s10484-013-9221-x

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