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

NCT07162311 | Enrolling By Invitation DMC

• 1 other identifier: 2024-0014
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatic Arthritis; Chronic Pain

Keywords

Rheumatoid arthrtis; chronic pain; tDCS

Outcome Measures

Primary Outcomes (1)

• VAS pain

  Visual Analogue Scale for pain

  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.

Study Arms (2)

Acitve tDCS

ACTIVE COMPARATOR

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

Device: tDCS

Sham tDCS

SHAM COMPARATOR

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

Device: tDCS

Interventions

tDCS DEVICE

Home-Based Transcranial Direct Current Stimulation

Acitve tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of brain surgery, traumatic brain injury, stroke, previous intracranial metal implantation, pregnancy, or breastfeeding.
• Previous history of autoimmune 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90880390, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37689323 BACKGROUND

MeSH Terms

Conditions

Rheumatic Fever; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; PhD Student in Medical Sciences at the Federal University of Rio Grande do Sul

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: September 9, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 22, 2028
• Study Completion (Estimated): December 22, 2028
• Last Updated: September 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)