Study of Transcranial Direct Current Stimulation Safety and Effectiveness in Adults With Systemic Autoimmune Myopathies

What this Trial Is About

This research aims to evaluate the safety and effectiveness of acute transcranial direct current stimulation in patients with systemic autoimmune myopathies, a group of diseases that mainly affect skeletal muscles. These diseases vary widely, and this study addresses the lack of previous research on using this stimulation technique in such patients. The study is designed as a prospective, randomized, double-blind, placebo-controlled trial to rigorously test this approach. Participants will be assigned randomly to one of two groups one receiving transcranial direct current stimulation and the other receiving a placebo session. The stimulation involves placing two electrodes on the head, targeting the primary motor cortex, with a mild electric current delivered for 20 minutes while the patient is seated. This procedure will be repeated once daily for three days. The placebo group will not receive the actual stimulation. During the study, participants will be monitored closely for safety by checking for any treatment-related side effects shortly after stimulation and again after eight weeks. Researchers will also assess muscle disease activity, muscle strength, patient and physician evaluations, and blood muscle enzyme levels before, shortly after, and at 3 and 8 weeks post-stimulation. The study lasts for several weeks with multiple assessments to understand the treatments impact and safety over time.

Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies