Highlights
- •High-definition transcranial direct current stimulation (HD-tDCS) provides targeted, specific, and tolerable subthreshold brain stimulation.
- •We present an optimized protocol option for the treatment of fibromyalgia (FM) pain.
- •We report a clinically significant benefit of a 50% pain reduction in patients with FM.
- •We estimate ∼15 HD-tDCS sessions to reach clinically meaningful outcomes.
Abstract
Despite promising preliminary results in treating fibromyalgia (FM) pain, no neuromodulation
technique has been adopted in clinical practice because of limited efficacy, low response
rate, or poor tolerability. This phase II open-label trial aims to define a methodology
for a clinically effective treatment of pain in FM by establishing treatment protocols
and screening procedures to maximize efficacy and response rate. High-definition transcranial
direct current stimulation (HD-tDCS) provides targeted subthreshold brain stimulation,
combining tolerability with specificity. We aimed to establish the number of HD-tDCS
sessions required to achieve a 50% FM pain reduction, and to characterize the biometrics
of the response, including brain network activation pain scores of contact heat-evoked
potentials. We report a clinically significant benefit of a 50% pain reduction in
half (n = 7) of the patients (N = 14), with responders and nonresponders alike benefiting
from a cumulative effect of treatment, reflected in significant pain reduction (P = .035) as well as improved quality of life (P = .001) over time. We also report an aggregate 6-week response rate of 50% of patients
and estimate 15 as the median number of HD-tDCS sessions to reach clinically meaningful
outcomes. The methodology for a pivotal FM neuromodulation clinical trial with individualized
treatment is thus supported.
Online Registration
Registered in Clinicaltrials.gov under registry number NCT01842009.
Perspective
In this article, an optimized protocol for the treatment of fibromyalgia pain with
targeted subthreshold brain stimulation using high-definition transcranial direct
current stimulation is outlined.
Key words
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Article info
Publication history
Published online: October 05, 2015
Accepted:
September 24,
2015
Received in revised form:
September 22,
2015
Received:
June 11,
2015
Footnotes
This research was supported in part by grants from Elminda, Ltd, Coulter Foundation (grant 75969-00-02), the National Institutes of Health (NIH grant 5U54CA132378-08, NIH/NSF grant 5R01MH092926-05) and the United States Department of Defense (grant FA9550-13-1-0073). The City University of New York owns patents on High-Definition tDCS with M.B., L.C.P., and A.D. as inventor. M.B., L.C.P., and A.D. have equity in Soterix Medical Inc.
Identification
Copyright
© 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.
