Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
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: Chronic transcranial direct current stimulation.
- Who it may be relevant to
- Registry conditions: Myopathy. Basic parameters: 18 years — 70 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 →
Unsure about the terms? Read our patient guide →
Overview
Systemic autoimmune myopathies are rheumatic diseases that affect the striatum 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 chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in the patients with systemic autoimmune myopathies.
Detailed description
Systemic autoimmune myopathies are rheumatic diseases that affect the striatum skeletal muscles. Depending on the clinical, pathophysiological and laboratory characteristics, they may be subdivided into polymyositis, dermatomyositis, antissintetase syndrome, immune-mediated necrotizing myopathy, and among others. Recently, the literature has been presenting better pharmacological treatment options to control these diseases. Despite these advances, this group of diseases still continues to be associated with high morbidity and functional disability, mainly due to the proximal muscular weakness of the scapular and pelvic girdles that may prevent the total recovery of these patients. On the other hand, the association of the transcranial current stimulation technique with motor recovery 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 chronic transcranial current stimulation session - associated with aerobic exercises - in patients with systemic autoimmune myopathies.
Interventions
- Other Chronic transcranial direct current stimulation
Chronic transcranial direct current stimulation
Primary outcome measures
- Frequency of treatment-emergent advser events [Time frame: After 30 minutes of intervention]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: Before stimulation]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: Immediately after all stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: After 30 days after last stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: After 60 days after last stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: After 90 days after last stimulation section]
- Frequency of treatment-emergent adverse events [safety and tolerability] [Time frame: After 300 days after last stimulation section]
Secondary outcome measures (10)
- Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT) [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Serum levels of Muscle enzymes [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Health Assessment Questionnaire (HAQ) [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Manual Muscle Testing (MMT) [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Patient Global Activity [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Physician Global Activity [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Fatigue Severity Scale [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Short Form McGill Pain Questionnaire 2 (SF-MPQ-2) [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Short Physical Performance Battery (SPPB) [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
- Timed up and go test [Time frame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section]
Eligibility criteria
Inclusion criteria
- Classification criteria - EULAR/ACR 2017
- Classification critera - Connors et al.
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
Publications
- Misse RG, Dos Santos AM, Borges IBP, Grecco MV, Faria MSMS, da Silva LRS, Correia BL, Kim AWS, Tanaka C, Greve JMD, Baptista AF, Shinjo SK. Impact of Transcranial Direct Current Stimulation in Pain, Fatigue, and Health Quality of Life of Patients with Idiopathic Inflammatory Myopathies: A Randomized, Double-Blind, Sham-Controlled Crossover Clinical Trial. Int J Rheumatol. 2024 Feb 1;2024:1583506. PMID 38332984
Identifiers
NCT: NCT04678635 · MYO-HCFMUSP-08