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Recruiting NCT03749538

Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

No phase Interventional Myopathy Neurologic Manifestations ElectroPhys: Myopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial direct current stimulation session..
Who it may be relevant to
Registry conditions: Myopathy, Neurologic Manifestations, ElectroPhys: Myopathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily affect the skeletal muscles. The transcranial direct current stimulation technique has been frequent, for example, in patients with ischemic stroke or for the optimization of muscular performance in athletes. However, to date, there are no studies evaluating this technique in patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of acute transcranial current stimulation session in patients with systemic autoimmune myopathies.

Detailed description

Currently, there are no studies evaluating the transcranial current stimulation technique in patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, double-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of acute transcranial direct current stimulation session in patients with systemic autoimmune myopathies.

Interventions

  • Other Transcranial direct current stimulation session.
    Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.

Primary outcome measures

  • Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: After 30 minutes of transcranial stimulation.]
  • Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: After 8 weeks of transcranial stimulation.]
Secondary outcome measures (6)
  • Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT) [Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.]
  • Serum levels of Muscle enzymes [Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.]
  • Health Assessment Questionnaire (HAQ) [Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation]
  • Manual Muscle Testing (MMT) [Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.]
  • Patient Global Activity [Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.]
  • Physician Global Activity [Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Brazil · 1 center
  • Samuel K Shinjo — São Paulo

Identifiers

NCT: NCT03749538 · MYO-HCFMUSP-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗