Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Myopathy Clinical Trial

Official title:

Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04678635
• Other study ID #: MYO-HCFMUSP-08
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Samuel K Shinjo, PhD
• Phone: 55113061-7176
• Email: samuel.shinjo[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 7, 2024
• Est. primary completion date: May 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Diseases
• Myopathy

Intervention

Other:
• Chronic transcranial direct current stimulation
Chronic transcranial direct current stimulation

Locations

Country	Name	City	State
Brazil	Samuel K Shinjo	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of treatment-emergent advser events	Frequency of disease relapses (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)	After 30 minutes of intervention
Primary	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)	Before stimulation
Primary	Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	Immediately after all stimulation section
Primary	Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 30 days after last stimulation section
Primary	Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 60 days after last stimulation section
Primary	Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 90 days after last stimulation section
Primary	Frequency of treatment-emergent adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome	After 300 days after last stimulation section
Secondary	Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)	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).	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Serum levels of Muscle enzymes	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.	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Health Assessment Questionnaire (HAQ)	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Manual Muscle Testing (MMT)	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)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Patient Global Activity	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)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Physician Global Activity	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)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Fatigue Severity Scale	The questionnaire offers general fatigue scored by the patients, from 0 (better) to 10 (worse).	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)	The questionnaire offers general pain scored by the patients, from 0 (better) to 10 (worse).	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Short Physical Performance Battery (SPPB)	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)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Secondary	Timed up and go test	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)	Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section