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NCT Number: NCT04678635

Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

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.

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Key information

Conditions

Myopathy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chronic transcranial direct current stimulation

Other

Chronic transcranial direct current stimulation

Primary outcomes

  1. Frequency of treatment-emergent advser events

    Time frame: After 30 minutes of intervention

    Frequency of disease relapses (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)

  2. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: Before stimulation

    Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)

  3. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: Immediately after all stimulation section

    Frequency of disease relapsing (based on the questionnaire of secondary outcome

  4. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: After 30 days after last stimulation section

    Frequency of disease relapsing (based on the questionnaire of secondary outcome

  5. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: After 60 days after last stimulation section

    Frequency of disease relapsing (based on the questionnaire of secondary outcome

  6. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: After 90 days after last stimulation section

    Frequency of disease relapsing (based on the questionnaire of secondary outcome

  7. Frequency of treatment-emergent adverse events [safety and tolerability]

    Time frame: After 300 days after last stimulation section

    Frequency of disease relapsing (based on the questionnaire of secondary outcome

Secondary outcomes

  1. Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)

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

    This partially validated tool measures the degree of disease activity of extra-muscular organ systems and muscle. The questionnaire is a series of physician's assessments of disease activity. Score ranges: 0 (best) - 60 (worst).

  2. Serum levels of Muscle enzymes

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

    This partially validated tool measures the serum activities of at least 2 of the 4 muscle-associated enzymes including creatine phosphokinase (CK), the transaminases (ALT, AST), lactate dehydrogenase (LD) and aldolase. The reference range value of each muscle enzyme will depend on the laboratory anaysis (kits). International Unit: U/L.

  3. Health Assessment Questionnaire (HAQ)

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

    Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)

  4. Manual Muscle Testing (MMT)

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

    This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies. Pontuaction: 0 (worst) - 80 (best)

  5. Patient Global Activity

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

    This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)

  6. Physician Global Activity

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

    This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale. Pontuaction: 0 (best) - 10 (worst)

  7. Fatigue Severity Scale

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

    The questionnaire offers general fatigue scored by the patients, from 0 (better) to 10 (worse).

  8. Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)

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

    The questionnaire offers general pain scored by the patients, from 0 (better) to 10 (worse).

  9. Short Physical Performance Battery (SPPB)

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

    The value ranges from 0 to 4 in different aspects of funcionality. The scores are compared among different periods of intervention (real or sham-stimulation)

  10. Timed up and go test

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

    To determine fall risk and measure the progress of balance, sit to stand and walking (seconds). The duration will be compared to before versus after intervation (real or sham-stimulation). Long duration (worse) versus short duration (better)

Study contacts

Contact information is provided by the study sponsor or research team.

Samuel K Shinjo, PhD

CONTACT

[email protected]

55113061-7176

Sao Paulo University

CONTACT

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 22, 2020
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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