Samuel K Shinjo
São Paulo, 01246903, Brazil
Location status: Recruiting
NCT Number: NCT03749538
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.
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Request Info18 year–80 year
All sexes
Interventional
Not applicable
São Paulo, 01246903, Brazil
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
Time frame: After 30 minutes of transcranial stimulation.
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time frame: After 8 weeks of transcranial stimulation.
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
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).
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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.
Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)
Time frame: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)
Contact information is provided by the study sponsor or research team.
University of Sao Paulo
Other
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