Actively Recruiting
Led by University of Sao Paulo · Updated on 2024-12-09
40
Participants Needed
1
Research Sites
30 weeks
Total Duration
Systemic autoimmune myopathies are rheumatic diseases affecting the striated skeletal muscles, including types such as polymyositis, dermatomyositis, and immune-mediated necrotizing myopathy. These diseases often cause significant muscle weakness and disability, despite improvements in pharmacological treatments. Researchers are evaluating the safety and effectiveness of chronic transcranial direct current stimulation combined with aerobic exercises in people with these myopathies through a prospective, randomized, double-blind, placebo-controlled study. Participants are assigned to one of two groups: one receives transcranial direct current stimulation while performing aerobic exercises, and the other performs aerobic exercises alone without stimulation. The stimulation involves applying a mild electrical current of 2mA through electrodes placed on the head over the primary motor cortex for 20 minutes during the exercise session. Each participant completes a total of 10 sessions. During the study, researchers monitor safety by tracking treatment-emergent adverse events before, immediately after, and at multiple points up to 300 days following the last stimulation session. Muscle disease activity, muscle enzyme levels, physical function, fatigue, pain, and global activity are assessed at the same intervals using various scales and physical tests. This comprehensive monitoring aims to evaluate both safety and potential benefits over time for up to nearly a year after treatment.
CONDITIONS
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of 10 sessions
Participants receive 10 sessions of transcranial direct current stimulation combined with aerobic exercises or sham stimulation with aerobic exercises.
10 visits (in-person)
Duration - Up to 300 days after last stimulation session
Participants are monitored for safety and efficacy up to 300 days after the last stimulation session.
Visits at immediate, 30, 60, 90, and 300 days after last session
Total: 1 location
1
Samuel K Shinjo
São Paulo, São Paulo, Brazil
Actively Recruiting
S
Samuel K Shinjo, PhD
S
Sao Paulo University
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Rafael Giovani Missé, Alexandre Moura Dos Santos, Isabela Bruna Pires Borges...
https://pubmed.ncbi.nlm.nih.gov/38332984