Evidence map›Paper›PMID 26456677›Full record

Trial reportThe journal of pain2016

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 and 6 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of pain, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01842009 (Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients), which is not on this map. Cited by 73 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 4 pooled it
7.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01842009 nacompletednot on this map

Single-arm, Open-label, Phase II Trial of HD-tDCS in Fibromyalgia Patients

TypeinterventionalSponsorSpaulding Rehabilitation HospitalRan2013 to 2016Enrolled20ConditionsFibromyalgia, Chronic PainArmsHigh Definition transcranial Direct Current Stimulation
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 4 syntheses or guidelines pooled it, 130 citations in OpenAlex.

  1. Pooled it
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  7. High-definition tDCS over primary motor cortex modulates brain signal variability and functional connectivity in episodic migraine.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2024
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  9. Better Fields or Currents? A Head-to-Head Comparison of Transcranial Magnetic (rTMS) Versus Direct Current Stimulation (tDCS) for Neuropathic Pain.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Trial
  10. Active and sham transcranial direct current stimulation (tDCS) improved quality of life in female patients with fibromyalgia.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Trial
  11. Effects of Personal Low-Frequency Stimulation Device on Myalgia: A Randomized Controlled Trial.International journal of environmental research and public health · 2022
    Trial
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  20. Review

13 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 3 countries.

Laura Castillo-SaavedraLaboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Nigel GebodhLaboratory 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.
Marom BiksonDepartment of Biomedical Engineering, The City College of the City University of New York, New York, New York.
Camilo Diaz-CruzLaboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Rivail BrandaoLaboratory 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.
Livia CoutinhoLaboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts.
Dennis TruongDepartment of Biomedical Engineering, The City College of the City University of New York, New York, New York.
Abhishek DattaDepartment of Biomedical Engineering, The City College of the City University of New York, New York, New York; Soterix Medical, Inc, New York, New York.
Revital Shani-HershkovichElMindA Ltd, Herzliya, Israel.
Michal WeissElMindA Ltd, Herzliya, Israel.
Ilan LauferElMindA Ltd, Herzliya, Israel.
Amit RechesElMindA Ltd, Herzliya, Israel.
Ziv PeremenElMindA Ltd, Herzliya, Israel; Tel Aviv University, Tel Aviv, Israel.
Amir GevaElMindA Ltd, Herzliya, Israel; Ben Gurion University, Beersheba, Israel.
Lucas C ParraDepartment of Biomedical Engineering, The City College of the City University of New York, New York, New York.
Felipe FregniLaboratory 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.
Hewlett-Packard (Israel) · ILCity College of New York · USMassachusetts General Hospital · USHarvard University · USBen-Gurion University of the Negev · ILSoterix Medical (United States) · USSpaulding Rehabilitation Hospital · USTel Aviv University · IL

Funding

Training and Career Development CoreU54CA132378 · NCI · CITY COLLEGE OF NEW YORK · PI Tim Alan Ahles, ADRIANA ESPINOSA · 2008 to 2026
$28.9M
CRCNS: Effects of Weak Applied Currents on Memory Consolidation During SleepR01MH092926 · NIMH · CITY COLLEGE OF NEW YORK · PI PARRA, LUCAS C · 2010 to 2014
$618k
TARGETED TRANSCRANIAL ELECTROTHERAPY SYSTEM TO ACCELERATE STROKE RECOVERYR41NS076123 · NINDS · SOTERIX MEDICAL,INC. · PI PARRA, LUCAS C · 2011 to 2012
$542k
NCI NIH HHS 5U54CA132378-08NCI NIH HHS U54 CA132378NIMH NIH HHS 5R01MH092926-05NIMH NIH HHS R01 MH092926NINDS NIH HHS R41 NS076123
6 · The paper itself

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.

Indexed as

Quality of LifeAdultAgedFemaleFibromyalgiaHot TemperatureHumansMaleMiddle AgedPain ManagementPain MeasurementPain ThresholdTranscranial Direct Current StimulationTreatment OutcomeFibromyalgiahigh-definition transcranial direct current stimulationmotor cortexnoninvasive brain stimulationpain

Identifiers

PMID26456677
PMCPMC5777157
OpenAlexW1925510761

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.