Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

NCT03749538 | Recruiting DMC

• 1 other identifier: MYO-HCFMUSP-06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopathy; Neurologic Manifestations; ElectroPhys: Myopathy

Outcome Measures

Primary Outcomes (2)

• 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)

  After 30 minutes of transcranial stimulation.

• 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)

  After 8 weeks of transcranial stimulation.

Secondary Outcomes (6)

• Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)

  3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.

• Serum levels of Muscle enzymes

  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)

  3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation

• Manual Muscle Testing (MMT)

  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

  4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.

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 positive charge (anode) will be positioned at contralateral to the dominant limb and the negative 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. During the session, patients will remain seated. Number of sessions: three times, once per day.

Other: Transcranial direct current stimulation session.

Placebo

PLACEBO COMPARATOR

This group will not receive a transcranial direct current stimulation session.

Other: Transcranial direct current stimulation session.

Interventions

Transcranial direct current stimulation session. OTHER

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

Placebo; Transcranial direct current stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: 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.
• Objective muscle limb weakness

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, 01246903, Brazil

RECRUITING

MeSH Terms

Conditions

Muscular Diseases; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel K Shinjo

  Universidade de Sao Paulo - Rheumatology Division

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel K Shinjo

CONTACT

1130617176; samuel.shinjo@gmail.com

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 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 a transcranial current stimulation session in patients with systemic autoimmune myopathies.

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 21, 2018
• Study Start: October 1, 2018
• Primary Completion: May 6, 2024
• Study Completion: December 4, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-12

Locations

BR (1)