Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Neurologic Manifestations Clinical Trial

Official title:

Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03749538
• Other study ID #: MYO-HCFMUSP-06
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 7, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Samuel K Shinjo
• Phone: 1130617176
• Email: samuel.shinjo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

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 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ElectroPhys: Myopathy
• Muscular Diseases
• Myopathy
• Neurologic Manifestations

Intervention

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

Locations

Country	Name	City	State
Brazil	Samuel K Shinjo	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 adverse events [safety and tolerability]	Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)	After 30 minutes of transcranial stimulation.
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)	After 8 weeks of transcranial stimulation.
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).	3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
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.	4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
Secondary	Health Assessment Questionnaire (HAQ)	Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)	3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
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)	4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)	4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)	4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.