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J Pain. 2016 Jan;17(1):14-26. doi: 10.1016/j.jpain.2015.09.009. Epub 2015 Oct 9.

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

Author information

1
Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
2
Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Department of Biomedical Engineering, The City College of the City University of New York, New York, New York.
3
Department of Biomedical Engineering, The City College of the City University of New York, New York, New York.
4
Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts; Postgraduate Program in Interactive Processes of Organs and Systems, Federal University of Bahia, Salvador, Bahia, Brazil.
5
Department of Biomedical Engineering, The City College of the City University of New York, New York, New York; Soterix Medical, Inc, New York, New York.
6
ElMindA Ltd, Herzliya, Israel.
7
ElMindA Ltd, Herzliya, Israel; Tel Aviv University, Tel Aviv, Israel.
8
ElMindA Ltd, Herzliya, Israel; Ben Gurion University, Beersheba, Israel.
9
Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: ffregni@mgh.harvard.edu.

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.

KEYWORDS:

Fibromyalgia; high-definition transcranial direct current stimulation; motor cortex; noninvasive brain stimulation; pain

PMID:
26456677
PMCID:
PMC5777157
DOI:
10.1016/j.jpain.2015.09.009
[Indexed for MEDLINE]
Free PMC Article

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