Clinical trial NCT04678635: Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Official title: Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, placebo-controlled study with application or not of chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in patients with systemic autoimmune myopathies.
Primary purpose: OTHER

Brief summary: 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.

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

Primary outcomes:
measure: Frequency of treatment-emergent advser events
timeFrame: After 30 minutes of intervention
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: Before stimulation
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: Immediately after all stimulation section
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: After 30 days after last stimulation section
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: After 60 days after last stimulation section
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: After 90 days after last stimulation section
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: After 300 days after last stimulation section
Secondary outcomes:
measure: Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Serum levels of Muscle enzymes
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Health Assessment Questionnaire (HAQ)
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Manual Muscle Testing (MMT)
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Patient Global Activity
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Physician Global Activity
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Fatigue Severity Scale
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Short Physical Performance Battery (SPPB)
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
measure: Timed up and go test
timeFrame: Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Samuel K Shinjo
state: Sao Paulo
Study officials:
affiliation: Brazil
name: Samuel K Shinjo
role: PRINCIPAL_INVESTIGATOR
References: