Clinically Effective Treatment of Fibromyalgia Pain with High-Definition Transcranial Direct Current Stimulation: Phase II Open-Label Dose Optimization

Laura Castillo-Saavedra, Nigel Gebodh, Marom Bikson, Camilo Diaz-Cruz, Rivail Brandao, Livia Coutinho, Dennis Truong, Abhishek Datta, Revital Shani-Hershkovich, Michal Weiss, Ilan Laufer, Amit Reches, Ziv Peremen, Amir Geva, Lucas C. Parra, Felipe Fregni

Research output: Contribution to journalArticlepeer-review

110 Scopus citations


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 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.

Original languageEnglish
Pages (from-to)14-26
Number of pages13
JournalJournal of Pain
Issue number1
StatePublished - 1 Jan 2016


  • Key words Fibromyalgia
  • high-definition transcranial direct current stimulation
  • motor cortex
  • noninvasive brain stimulation
  • pain

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine


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