Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04678635
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2020-12-12
Brief Title:
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None