ClinicalTrials.gg
Enrolling by invitationNCT07162311tDCS RAUpdated Sep 9, 2025

Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity

An interventional study of tDCS in Rheumatic Arthritis and Chronic Pain, sponsored by Federal University of Rio Grande do Sul. Enrolling by invitation at 1 site in Brazil. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2024, registered Apr 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study summary

Rheumatoid arthritis (RA) is a highly complex inflammatory autoimmune disease. Several drugs have been developed in recent decades to target the immune components of inflammation. However, even with effective anti-inflammatory and immunosuppressive therapies for controlling RA, many patients still report significant levels of chronic pain due to CNS neuroplasticity, perpetuating physical disability, psychosocial problems, decreased work activity, and poor quality of life. In addition, chronic pain can lead to increased public spending due to the need for more medical visits, ineffective drug treatments, and financial disability benefits. Transcranial stimulation (a noninvasive neural stimulation technique with minimal adverse effects and easy home use) has been a promising adjunct tool in the treatment of chronic pain and psychological disorders in diseases that affect the central nervous system in the long term. Thus, exploring transcranial direct current stimulation in RA patients with low levels of inflammation could impact on improving pain, functionality, psychological aspects and overall quality of life, as well as reducing healthcare costs for society.

Read the detailed description

Rheumatoid arthritis (RA) is a highly complex inflammatory autoimmune disease. Several drugs have been developed in recent decades to target the immune components of inflammation. However, even with effective anti-inflammatory and immunosuppressive therapies for controlling RA, many patients still report significant levels of chronic pain due to CNS neuroplasticity, perpetuating physical disability, psychosocial problems, decreased work activity, and poor quality of life. In addition, chronic pain can lead to increased public spending due to the need for more medical visits, ineffective drug treatments, and financial disability benefits. Transcranial stimulation (a noninvasive neural stimulation technique with minimal adverse effects and easy home use) has been a promising adjunct tool in the treatment of chronic pain and psychological disorders in diseases that affect the central nervous system in the long term. Thus, exploring transcranial direct current stimulation in RA patients with low levels of inflammation could impact on improving pain, functionality, psychological aspects and overall quality of life, as well as reducing healthcare costs for society.

02

Conditions studied

  • Rheumatic Arthritis
  • Chronic Pain

Keywords

  • Rheumatoid arthrtis
  • chronic pain
  • tDCS
03

In context

Rheumatic Fever

55 studies on the registry are indexed under Rheumatic Fever; 21 are open to participants now.

This study's planned enrollment of 34 is below the median of 70 across 28 interventional studies indexed under Rheumatic Fever.

Browse Rheumatic Fever studies →

Lead sponsor

Federal University of Rio Grande do Sul is the lead sponsor of 121 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants aged 18-70 with RA.
  • Participants with generalized pain ≥ 40 mm on the VAS-Pain scale, lasting over 3 months, and not of mechanical or inflammatory origin, as assessed by a certified rheumatologist.
  • Evidence of low inflammatory markers, including with C-reactive protein (CRP) \<10 mg/dL and sedimentation rate (ESR) \<20 mm/h, and stable treatment for PsA for at least 6 months prior to study enrollment.

Exclusion criteria

Exclusion Criteria:

  • History of brain surgery, traumatic brain injury, stroke, previous intracranial metal implantation, pregnancy, or breastfeeding.
  • Previous history of diseases other than RA.
  • History of neurological diseases.
  • Previous history of neoplasia.
  • History of any other uncompensated clinical disease.
  • Use of illicit drugs within the past 6 months.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (estimated)

Study arms

  • Active comparator
    Acitve tDCS

    2 mA, 20 minutes/day, 5 days/week, for 4 weeks, applied at home under remote supervision.

    Device: tDCS

  • Sham comparator
    Sham tDCS

    Same parameters as active tDCS, but current was ramped down after 30 seconds to mimic sensation without delivering stimulation.

    Device: tDCS

Interventions

  • DevicetDCS

    Home-Based Transcranial Direct Current Stimulation

06

What researchers measure

Primary outcomes

  1. VAS pain

    Visual Analogue Scale for pain

    Time frame: Visual Analog Scale (VAS, 0-100 mm; higher scores indicate worse pain) assessed at baseline (Day 1), after 10 days of tDCS treatment, at Week 4 of tDCS treatment (end of treatment), and at 3, 6, 9, and 12 months post-treatment.

07

Study locations

1 site
08

References and documents

Publications

  • Caumo W, Lopes Ramos R, Vicuna Serrano P, da Silveira Alves CF, Medeiros L, Ramalho L, Tomeddi R, Bruck S, Boher L, Sanches PRS, Silva DP Jr, Ls Torres I, Fregni F. Efficacy of Home-Based Transcranial Direct Current Stimulation Over the Primary Motor Cortex and Dorsolateral Prefrontal Cortex in the Disability Due to Pain in Fibromyalgia: A Factorial Sham-Randomized Clinical Study. J Pain. 2024 Feb;25(2):376-392. doi: 10.1016/j.jpain.2023.09.001. Epub 2023 Sep 7. PubMed 37689323 ↗

Individual participant data

Plan to share: No — The Individual Patient Data (IPD) will not be shared due to privacy and confidentiality concerns, as well as the protection of sensitive patient information. Additionally, there may be legal or regulatory restrictions that prevent the release of such data. Sharing of IPD could also raise ethical issues regarding informed consent and the use of data beyond the initial scope of the study.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07162311
Responsible party
Stephanie Pilotti (Principal Investigator; PhD Student in Medical Sciences at the Federal University of Rio Grande do Sul, Federal University of Rio Grande do Sul) — Principal investigator
First posted
Sep 9, 2025
Start date
Jan 1, 2024
Primary completion
Dec 22, 2028 (estimated)
Completion
Dec 22, 2028 (estimated)
Last update
Sep 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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