Clinical trial NCT03749538: Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Official title: Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopathy
Neurologic Manifestations
ElectroPhys: Myopathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, double-blind, placebo-controlled study with application or not of a transcranial current stimulation session in patients with systemic autoimmune myopathies.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: After 30 minutes of transcranial stimulation.
measure: Frequency of treatment-emergent adverse events [safety and tolerability]
timeFrame: After 8 weeks of transcranial stimulation.
Secondary outcomes:
measure: Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
timeFrame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
measure: Serum levels of Muscle enzymes
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
measure: Health Assessment Questionnaire (HAQ)
timeFrame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
measure: Manual Muscle Testing (MMT)
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
measure: Patient Global Activity
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
measure: Physician Global Activity
timeFrame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel K Shinjo
Study officials:
affiliation: Universidade de Sao Paulo - Rheumatology Division
name: Samuel K Shinjo
role: PRINCIPAL_INVESTIGATOR
References: