Rheumatic ArthritistDCS RANCT07162311
Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity
A study testing tDCS in people with Rheumatic Arthritis and Chronic Pain, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatic Arthritis, Chronic Pain
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2024to 22 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90880390
About this study
Official title: Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
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.
- Conditions
- Rheumatic Arthritis, Chronic Pain
- Being tested
- tDCS
- Keywords
- Rheumatoid arthrtis, chronic pain, tDCS
- Medical subject headings
- Rheumatic Fever, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Home-Based Transcranial Direct Current Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Acitve tDCS | Active comparator | 2 mA, 20 minutes/day, 5 days/week, for 4 weeks, applied at home under remote supervision. Receives: 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain
Visual Analogue Scale for pain
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jan 2024
- Primary completion22 Dec 2028 (estimated)
- Study completion22 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Pilotti, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162311
- Sponsor's protocol ID
- 2024-0014
- Acronym
- tDCS RA
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-Based Transcranial Direct Current Stimulation on Pain in Patients With Rheumatoid Arthritis With Low Inflammatory Activity: A Randomized, Double-Blind, Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07162311
- Acronym / sponsor ID
- tDCS RA / 2024-0014
- Conditions
- Rheumatic Arthritis, Chronic Pain
- Keywords
- Rheumatoid arthrtis, chronic pain, tDCS
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 22 Dec 2028 (estimated)
- Study completion
- 22 Dec 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acitve tDCS | Active comparator | Device: tDCS2 mA, 20 minutes/day, 5 days/week, for 4 weeks, applied at home under remote supervision. |
| Sham tDCS | Sham comparator | Device: tDCSSame parameters as active tDCS, but current was ramped down after 30 seconds to mimic sensation without delivering stimulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSHome-Based Transcranial Direct Current Stimulation | Device | Acitve tDCS, Sham tDCS |
Primary outcome
VAS 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.
Visual Analogue Scale for pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Background: PubMed 37689323Caumo 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Rheumatic Arthritis and Chronic Pain, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07162311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.