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Randomized Controlled Trial
. 2025 Jun 2;8(6):e2514262.
doi: 10.1001/jamanetworkopen.2025.14262.

Home-Based Transcranial Direct Current Stimulation vs Placebo for Fibromyalgia: A Randomized Clinical Trial

Wolnei Caumo  1   2   3 , Barbara Regina Franca  1   2 , Roman Orzechowski  1   2   3 , Graziele Bueno  1   2 , Arthur França de Souza  2 , Jéssica Vebber Dos Santos da Silva  2 , Paulo R S Sanches  4 , Danton P Da Silva Jr  4 , Iraci L S Torres  1   5 , Vania Naomi Hirakata  6   7 , Kevin Pacheco-Barrios  8   9 , Felipe Fregni  8
Affiliations
Randomized Controlled Trial

Home-Based Transcranial Direct Current Stimulation vs Placebo for Fibromyalgia: A Randomized Clinical Trial

Wolnei Caumo et al. JAMA Netw Open. .

Erratum in

  • Error in the Byline.
    [No authors listed] [No authors listed] JAMA Netw Open. 2025 Jul 1;8(7):e2526572. doi: 10.1001/jamanetworkopen.2025.26572. JAMA Netw Open. 2025. PMID: 40674057 Free PMC article. No abstract available.
  • Error in the Byline.
    [No authors listed] [No authors listed] JAMA Netw Open. 2025 Oct 1;8(10):e2540518. doi: 10.1001/jamanetworkopen.2025.40518. JAMA Netw Open. 2025. PMID: 41037272 Free PMC article. No abstract available.

Abstract

Importance: Previous trials with smaller samples and shorter follow-up periods showed that multiple-session home-based anodal transcranial direct current stimulation (A-tDCS) on the left dorsolateral prefrontal cortex (DLPFC) improved fibromyalgia symptoms. However, the duration of the effect, the influence of exercise and pain neuroscience education (PNE), and the role of placebo remain unclear.

Objective: To evaluate whether A-tDCS targeting the left DLPFC, combined with exercise and PNE, is more effective than sham tDCS in reducing pain and disability, based on placebo-test responses (responders vs nonresponders).

Design, setting, and participants: This double-blind, sham-controlled randomized clinical trial enrolled women aged 18 to 65 years with fibromyalgia. Participants were randomized to receive A-tDCS or sham tDCS between April 2022 and April 2024. They were treated at home and at the outpatient Clinical Research Center of Hospital de Clínicas de Porto Alegre in Porto Alegre, Brazil. Exclusion criteria included tDCS contraindications and uncontrolled clinical conditions. Intention-to-treat analyses were conducted from July to December 2024.

Interventions: Home-based tDCS (2 mA; 20 minutes daily) or sham tDCS (2 mA; 30 seconds at the start, then 10 minutes, and then 20 minutes, with a 20-second ramp-up and ramp-down) for 4 weeks with anodal-left and cathodal-right prefrontal stimulation (35 cm2 electrodes), combined with exercise and PNE via videos and remote supervision following in-person training.

Main outcomes and measures: Change in Multidimensional Pain Interference Index (MPII) at treatment end and 3-month follow-up. MPII was measured by the Brief Pain Inventory, a 7-item scale that assesses the impact of pain on daily activities, emotional well-being, and social interactions.

Results: A total of 112 female patients (mean [SD] age, 49.04 [9.71] years) were included and randomized to either A-tDCS (n = 56 placebo nonresponders) or sham tDCS (n = 56 placebo responders). In the intention-to-treat analysis, linear mixed-effects models showed reduced MPII by 38.76% (95% CI, -41.90% to -30.92%) for the A-tDCS group vs 16.08% (95% CI, -21.42% to -10.41%) for sham tDCS (mean difference [MD], 22.68%; 95% CI, 12.79%-40.00%; Cohen d = 0.73). A significant treatment-by-time interaction favored A-tDCS across 5 assessments, with no interaction by placebo response. In placebo responders, MPII was reduced by 34.21% (95% CI, -46.88% to -28.29%) for A-tDCS vs 18.13% (95% CI, -24.90% to 3.34%) for sham tDCS (MD, 24.23%; 95% CI, 15.80%-32.67%). Among placebo nonresponders, MPII decreases were 35.49% (95% CI, -41.21% to -29.53%) for A-tDCS vs 25.96% (95% CI, -34.31% to -20.42%) for sham tDCS (MD, 9.52%; 95% CI, 2.79%-19.78%). Improvement in MPII of 50% or more was achieved by 62.5% of participants (n = 35) in the A-tDCS group vs 37.5% (n = 21) in the sham tDCS group (relative risk, 0.60; 95% CI, 0.39-0.91).

Conclusions and relevance: This trial found that A-tDCS along with exercise and PNE improved disability due to pain, especially in placebo test responders. The findings support fibromyalgia management and enhance understanding of tDCS-related placebo effects.

Trial registration: ClinicalTrials.gov Identifier: NCT05845528.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Caumo reported holding a pending patent for BR 20 2015 016450 0 U2, receiving licensing royalties from Quark Medical, and receiving grants from Foundation for the Support of Research at Rio Grande do Sul (FAPERGS) Ministry of Science and Technology during the conduct of the study. Dr Sanches reported holding a pending patent for BR 20 2015 016450 0 U2, receiving licensing royalties from Quark Medical, and receiving grants from FAPERGS Ministry of Science and Technology during the conduct of the study. Dr Da Silva reported receiving grants from FAPERGS Ministry of Science and Technology during the conduct of the study. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flow Diagram
A-tDCS indicates anodal transcranial direct current stimulation; ITT, intention to treat; tDCS, transcranial direct current stimulation.
Figure 2.
Figure 2.. Change in Multidimensional Pain Interference Index (MPII) Over Time
Linear mixed-effects models assessed the effect of treatment—anodal transcranial direct current stimulation (A-tDCS) vs sham transcranial direct current stimulation (tDCS)—combined with exercise and pain neuroscience education on MPII (as measured by the 7-item Brief Pain Inventory), adjusted for analgesic use. Solid lines represent mean scores at each time point (weeks 0-12), and shaded areas represent 95% CIs. Overlapping CIs indicate no differences between treatments.
See this image and copyright information in PMC

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