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

Federal University of Rio Grande do Sul

Status: Invitation-only

Conditions: Rheumatic Arthritis; Chronic Pain

Treatments: Device: tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT07162311

2024-0014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups

Acitve tDCS

Active Comparator group

Description:

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

Treatment:

Device: tDCS

Sham tDCS

Sham Comparator group

Description:

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

Treatment:

Device: tDCS