Using brain stimulation to help patients with autoimmune muscle diseases
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
This study is testing if a new brain stimulation treatment combined with exercise can help people with autoimmune muscle diseases feel stronger and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT04678635 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of chronic transcranial direct current stimulation combined with aerobic exercises in patients suffering from systemic autoimmune myopathies. These conditions lead to significant muscle weakness and functional disability, and the study aims to explore a novel therapeutic approach that has not been previously tested in this patient population. It is a prospective, randomized, double-blind, placebo-controlled design, ensuring rigorous assessment of the intervention's effects. The goal is to determine if this technique can improve muscle function and overall quality of life for affected individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with systemic autoimmune myopathies who meet specific classification criteria.
Not a fit: Patients with neoplasia, heart pacemakers, visceral metallic clips, infections, pregnancy, or a history of seizures or epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance muscle recovery and functional ability in patients with systemic autoimmune myopathies.
How similar studies have performed: While transcranial direct current stimulation has shown promise in other conditions, this specific application in systemic autoimmune myopathies is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Classification criteria - EULAR/ACR 2017 * Classification critera - Connors et al. Exclusion Criteria: * Neoplasia * Using heart pacemarker * Using visceral metalic clips * Infections (HIV, HTLV-1, Hepatitis, etc) * Pregnance * Previous historical of convulsions or epilepsies
Where this trial is running
São Paulo, São Paulo
- Samuel K Shinjo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Samuel K Shinjo — Brazil
- Study coordinator: Samuel K Shinjo, PhD
- Email: samuel.shinjo@usp.br
- Phone: 55113061-7176
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.