Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

University of Sao Paulo

Status: Enrolling

Conditions: Neurologic Manifestations; Myopathy; ElectroPhys: Myopathy

Treatments: Other: Transcranial direct current stimulation session.

Study type: Interventional

Funder types: Other

Identifiers

NCT03749538

MYO-HCFMUSP-06

Details and patient eligibility

About

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.

Full description

Currently, there are no studies evaluating the transcranial current stimulation 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 direct current stimulation session in patients with systemic autoimmune myopathies.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Classification criteria - EULAR/ACR 2017
• Classification critera - Connors et al.
• Objective muscle limb weakness

Exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Transcranial direct current stimulation

Experimental group

Description:

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.

Treatment:

Other: Transcranial direct current stimulation session.

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Transcranial direct current stimulation session.