- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03749538
Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
May 16, 2023 updated by: Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
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.
Study Overview
Status
Recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Samuel K Shinjo
- Phone Number: 1130617176
- Email: samuel.shinjo@gmail.com
Study Contact Backup
- Name: Sao Paulo University
Study Locations
-
-
-
Sao Paulo, Brazil, 01246903
- Recruiting
- Samuel K Shinjo
-
Contact:
- Samuel K Shinjo
- Phone Number: 1130617176
- Email: samuel.shinjo@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Transcranial direct current stimulation
Transcranial direct current stimulation session: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head.
The electrodes will be located of the primary motor cortex.
The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb.
The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes.
During the session, patients will remain seated.
Number of sessions: three times, once per day.
|
Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
|
Placebo Comparator: Placebo
This group will not receive a transcranial direct current stimulation session.
|
Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of treatment-emergent adverse events [safety and tolerability]
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)
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After 30 minutes of transcranial stimulation.
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Frequency of treatment-emergent adverse events [safety and tolerability]
Time Frame: After 8 weeks of transcranial stimulation.
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Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
|
After 8 weeks of transcranial stimulation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
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).
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3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
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Serum levels of Muscle enzymes
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.
|
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
|
Health Assessment Questionnaire (HAQ)
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)
|
3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
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Manual Muscle Testing (MMT)
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)
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4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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Patient Global Activity
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)
|
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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Physician Global Activity
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)
|
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samuel K Shinjo, Universidade de Sao Paulo - Rheumatology Division
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Anticipated)
May 16, 2023
Study Completion (Anticipated)
May 16, 2023
Study Registration Dates
First Submitted
November 16, 2018
First Submitted That Met QC Criteria
November 20, 2018
First Posted (Actual)
November 21, 2018
Study Record Updates
Last Update Posted (Actual)
May 17, 2023
Last Update Submitted That Met QC Criteria
May 16, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MYO-HCFMUSP-06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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