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Targeting the Autonomic Nervous System Balance in Patients with Chronic Low Back Pain using Transcranial Alternating Current Stimulation: A Randomized, Crossover, Double-Blind, Placebo-Controlled Pilot Study

Julianna H. Prim, Sangtae Ahn, Maria I. Davila, Morgan L. Alexander, Karen L. McCulloch, Flavio Fröhlich
doi: https://doi.org/10.1101/668541
Julianna H. Prim
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Human Movement Science Curriculum, University of North Carolina at Chapel Hill, Chapel Hill NC 27599
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Sangtae Ahn
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill NC 27599
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Maria I. Davila
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill NC 27599
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Morgan L. Alexander
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill NC 27599
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Karen L. McCulloch
Human Movement Science Curriculum, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Division of Physical Therapy, University of North Carolina at Chapel Hill, Chapel Hill NC 27599
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Flavio Fröhlich
Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill NC 27599Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill NC 27599
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  • For correspondence: flavio_frohlich@med.unc.edu
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Abstract

Background Chronic low back pain (CLBP) is characterized by an alteration in pain processing by the central nervous system that may affect autonomic nervous system (ANS) balance. Heart rate variability (HRV) reflects the balance of parasympathetic and sympathetic ANS activation. In particular, respiratory sinus arrhythmia (RSA) solely reflects parasympathetic input and is reduced in CLBP patients. Yet, it remains unknown if non-invasive brain stimulation can alter ANS balance in CLBP patients.

Objective To evaluate if non-invasive brain stimulation modulates the ANS, we analyzed HRV metrics collected in a previously published study of transcranial alternating current stimulation (tACS) for the modulation of CLBP through enhancing alpha oscillations. We hypothesized that tACS would increase RSA.

Methods A randomized, crossover, double-blind, sham-controlled pilot study was conducted to investigate the effects of 10Hz-tACS on metrics of ANS balance calculated from electrocardiogram (ECG). ECG data were collected for 2 minutes before and after 40 minutes of 10Hz-tACS or sham stimulation.

Results There were no significant changes in RSA or other frequency-domain HRV components from 10Hz-tACS. However, exploratory time-domain HRV analysis revealed a significant increase in the standard deviation of normal RR intervals (SDNN) for 10Hz-tACS relative to sham.

Conclusion(s) Although tACS did not significantly increase RSA, we found in an exploratory analysis that tACS modulated an integrated HRV measure of both ANS branches. These findings support the further study of how the ANS and alpha oscillations interact and are modulated by tACS.

Footnotes

  • ClinicalTrials.gov: Transcranial Alternating Current Stimulation in Back Pain- Pilot Study, NCT03243084

  • Funding Source: This work was supported by the National Institute of Mental Health of the National Institutes of Health under Award Numbers R01MH111889 and R01MH101547, the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health, through Grant Award Number UL1TR002489.

  • Conflict of Interest: J.H.P, S.A., M.I.D., M.L.A., and K.L.M. have no financial conflicts. F.F.is the lead inventor of IP filed by UNC. The clinical studies performed in the Frohlich Lab have received a designation as conflict of interest with administrative considerations. F.F.is the founder, CSO and majority owner of Pulvinar Neuro LLC, a company that markets research tDCS and tACS devices for research only. Pulvinar Neuro played no role in the study reported here. F.F. has received research funding from the National Institute of Health, the Brain Behavior Foundation, the Foundation of Hope, the Human Frontier Science Program, Tal Medical, NeuroCare Group, and individual donations. F.F. is an adjunct professor in Neurology at the Insel Hospital of the University of Bern, Switzerland. F.F. receives royalties for his textbook Network Neuroscience published by Academic Press.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted June 20, 2019.
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Targeting the Autonomic Nervous System Balance in Patients with Chronic Low Back Pain using Transcranial Alternating Current Stimulation: A Randomized, Crossover, Double-Blind, Placebo-Controlled Pilot Study
Julianna H. Prim, Sangtae Ahn, Maria I. Davila, Morgan L. Alexander, Karen L. McCulloch, Flavio Fröhlich
bioRxiv 668541; doi: https://doi.org/10.1101/668541
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Targeting the Autonomic Nervous System Balance in Patients with Chronic Low Back Pain using Transcranial Alternating Current Stimulation: A Randomized, Crossover, Double-Blind, Placebo-Controlled Pilot Study
Julianna H. Prim, Sangtae Ahn, Maria I. Davila, Morgan L. Alexander, Karen L. McCulloch, Flavio Fröhlich
bioRxiv 668541; doi: https://doi.org/10.1101/668541

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