Using brain stimulation to treat muscle weakness in autoimmune myopathy patients
Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
This study is testing if a new type of brain stimulation can help people with autoimmune myopathy improve their muscle strength and overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT03749538 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of acute transcranial direct current stimulation in patients diagnosed with systemic autoimmune myopathies, a group of diseases that primarily affect skeletal muscles. It employs a prospective, randomized, double-blind, placebo-controlled design to ensure robust results. The goal is to determine whether this non-invasive brain stimulation technique can improve muscle function and overall patient outcomes. Currently, there are no existing studies that have explored this approach in the context of autoimmune myopathies.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with systemic autoimmune myopathies who exhibit objective muscle limb weakness.
Not a fit: Patients with neoplasia, heart pacemakers, visceral metallic clips, infections, pregnancy, or a history of convulsions or epilepsies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for improving muscle strength and function in patients with systemic autoimmune myopathies.
How similar studies have performed: While transcranial direct current stimulation has been studied in other contexts, such as stroke recovery and athletic performance, 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. * Objective muscle limb weakness 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
- Samuel K Shinjo — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Samuel K Shinjo — Universidade de Sao Paulo - Rheumatology Division
- Study coordinator: Samuel K Shinjo
- Email: samuel.shinjo@gmail.com
- Phone: 1130617176
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.