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Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

NCT ID: NCT03749538

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2024-12-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myopathy Neurologic Manifestations ElectroPhys: Myopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized, double-blind, placebo-controlled study with application or not of a transcranial current stimulation session in patients with systemic autoimmune myopathies.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind study to transcranial current stimulation

Study Groups

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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 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.

Group Type EXPERIMENTAL

Transcranial direct current stimulation session.

Intervention Type OTHER

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Transcranial direct current stimulation session.

Intervention Type OTHER

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

Interventions

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Transcranial direct current stimulation session.

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Samuel Katsuyuki Shinjo, PhD

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Samuel K Shinjo

Role: PRINCIPAL_INVESTIGATOR

Universidade de Sao Paulo - Rheumatology Division

Locations

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Samuel K Shinjo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Samuel K Shinjo

Role: CONTACT

Phone: 1130617176

Email: [email protected]

Sao Paulo University

Role: CONTACT

Facility Contacts

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Samuel K Shinjo

Role: primary

Other Identifiers

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MYO-HCFMUSP-06

Identifier Type: -

Identifier Source: org_study_id