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Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

NCT ID: NCT04678635

Last Updated: 2024-12-09

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

2020-12-12

Study Completion Date

2024-12-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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 chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in patients with systemic autoimmune myopathies.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind study to transcranial direct 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 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

Group Type EXPERIMENTAL

Chronic transcranial direct current stimulation

Intervention Type OTHER

Chronic transcranial direct current stimulation

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

Group Type PLACEBO_COMPARATOR

Chronic transcranial direct current stimulation

Intervention Type OTHER

Chronic transcranial direct current stimulation

Interventions

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Chronic transcranial direct current stimulation

Chronic transcranial direct current stimulation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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

Brazil

Locations

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Samuel K Shinjo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Samuel K Shinjo, PhD

Role: CONTACT

Phone: 55113061-7176

Email: [email protected]

Sao Paulo University

Role: CONTACT

Facility Contacts

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Samuel K Shinjo, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38332984 (View on PubMed)

Other Identifiers

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MYO-HCFMUSP-08

Identifier Type: -

Identifier Source: org_study_id