Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

NCT04678635 | Recruiting DMC

• 1 other identifier: MYO-HCFMUSP-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopathy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (10)

• Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)

  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

  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)

  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)

  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

  Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Chronic transcranial direct current stimulation OTHER

Chronic transcranial direct current stimulation

Placebo; Transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Yes Participant eligibility is based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Classification criteria - EULAR/ACR 2017
• Classification critera - Connors et al.

You may not qualify if:

• Neoplasia
• Using heart pacemarker
• Using visceral metalic clips
• Infections (HIV, HTLV-1, Hepatitis, etc)
• Pregnance
• Previous historical of convulsions or epilepsies

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Samuel K Shinjo

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (1)

• 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. doi: 10.1155/2024/1583506. eCollection 2024.

  PMID: 38332984 DERIVED

MeSH Terms

Conditions

Muscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Samuel K Shinjo

  Brazil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel K Shinjo, PhD

CONTACT

55113061-7176; samuel.shinjo@usp.br

Sao Paulo University

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study to transcranial direct current stimulation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: 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.

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 22, 2020
• Study Start: December 12, 2020
• Primary Completion: May 6, 2024
• Study Completion: December 4, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)