Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

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.

Study Overview

• Status: Recruiting
• Conditions: Myopathy
• Intervention / Treatment: Other: Chronic transcranial direct current stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sao Paulo University
• Study Contact Backup: Name: Samuel K Shinjo, PhD; Phone Number: 55113061-7176; Email: samuel.shinjo@usp.br

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil
      • Recruiting
      • Samuel K Shinjo
      • Contact: Samuel K Shinjo, PhD; Phone Number: 551130617176; Email: samuel.shinjo@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial direct current stimulation; Transcranial direct current stimulation session: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with cathode will be positioned at contralateral to the dominant limb and the anode charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes. The stimulation will happen simultaneously to aerobic exercises for 20 minutes. Total number of stimulation associated with aerobic exercise sessions: 10	Other: Chronic transcranial direct current stimulation; Chronic transcranial direct current stimulation
Placebo Comparator: Placebo; This group will not receive a transcranial direct current stimulation session. However, the patients will do aerobic exercises for 20 minutes. Total number of sham-stimulation associated with aerobic exercise sessions: 10	Other: Chronic transcranial direct current stimulation; Chronic transcranial direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of treatment-emergent advser events	Frequency of disease relapses (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)	After 30 minutes of intervention
Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)	Before stimulation
Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	Immediately after all stimulation section
Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 30 days after last stimulation section
Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 60 days after last stimulation section
Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 90 days after last stimulation section
Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 300 days after last stimulation section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)	This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. The questionnaire is a series of physician's assessments of disease activity. Score ranges: 0 (best) - 60 (worst).	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	This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. The reference range value of each muscle enzyme will depend on the laboratory anaysis (kits). International Unit: U/L.	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)	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)	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)	This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. Pontuaction: 0 (worst) - 80 (best)	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	This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)	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	This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)	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	The questionnaire offers general fatigue scored by the patients, from 0 (better) to 10 (worse).	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)	The questionnaire offers general pain scored by the patients, from 0 (better) to 10 (worse).	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)	The value ranges from 0 to 4 in different aspects of funcionality. The scores are compared among different periods of intervention (real or sham-stimulation)	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	To determine fall risk and measure the progress of balance, sit to stand and walking (seconds). The duration will be compared to before versus after intervation (real or sham-stimulation). Long duration (worse) versus short duration (better)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Samuel K Shinjo, BRAZIL

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Anticipated): May 16, 2023
• Study Completion (Anticipated): May 16, 2023

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Muscular Diseases
• Other Study ID Numbers: MYO-HCFMUSP-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No