Actively Recruiting
Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Led by University of Sao Paulo · Updated on 2024-12-05
40
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
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 treatment's impact and safety over time.
CONDITIONS
Brief Title
Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic autoimmune myopathy based on EULAR/ACR 2017 criteria or Connors et al. criteria
- Objective muscle limb weakness present
- Age between 18 and 80 years
You will not qualify if you...
- Diagnosis of any neoplasia (cancer)
- Use of a heart pacemaker
- Presence of metallic clips inside the body
- Active infections such as HIV, HTLV-1, or Hepatitis
- Pregnancy
- History of seizures or epilepsy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants receive either active transcranial direct current stimulation sessions or placebo sessions. Active stimulation involves three daily sessions of 20 minutes each.
3 daily visits (in-person) for stimulation sessions
Duration - 8 weeks
Participants are monitored for safety and efficacy outcomes up to 8 weeks after stimulation.
Assessments at 30 minutes, 3 weeks, and 8 weeks after last stimulation
Trial Site Locations
Total: 1 location
1
Samuel K Shinjo
São Paulo, Brazil, 01246903
Actively Recruiting
Research Team
S
Samuel K Shinjo
S
Sao Paulo University
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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