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Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Primary Purpose

Myopathy

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Chronic transcranial direct current stimulation
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Myopathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Classification criteria - EULAR/ACR 2017
  • Classification critera - Connors et al.

Exclusion Criteria:

  • Neoplasia
  • Using heart pacemarker
  • Using visceral metalic clips
  • Infections (HIV, HTLV-1, Hepatitis, etc)
  • Pregnance
  • Previous historical of convulsions or epilepsies

Sites / Locations

  • Samuel K ShinjoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Transcranial direct current stimulation

Placebo

Arm Description

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 cathode will be positioned at contralateral to the dominant limb and the anode 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. The stimulation will happen simultaneously to aerobic exercises for 20 minutes. Total number of stimulation associated with aerobic exercise sessions: 10

This group will not receive a transcranial direct current stimulation session. However, the patients will do aerobic exercises for 20 minutes. Total number of sham-stimulation associated with aerobic exercise sessions: 10

Outcomes

Primary Outcome Measures

Frequency of treatment-emergent advser events
Frequency of disease relapses (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
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)
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome

Secondary Outcome Measures

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).
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.
Health Assessment Questionnaire (HAQ)
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
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)
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)
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)
Fatigue Severity Scale
The questionnaire offers general fatigue scored by the patients, from 0 (better) to 10 (worse).
Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)
The questionnaire offers general pain scored by the patients, from 0 (better) to 10 (worse).
Short Physical Performance Battery (SPPB)
The value ranges from 0 to 4 in different aspects of funcionality. The scores are compared among different periods of intervention (real or sham-stimulation)
Timed up and go test
To determine fall risk and measure the progress of balance, sit to stand and walking (seconds). The duration will be compared to before versus after intervation (real or sham-stimulation). Long duration (worse) versus short duration (better)

Full Information

First Posted
December 12, 2020
Last Updated
May 16, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04678635
Brief Title
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Official Title
Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
May 16, 2023 (Anticipated)
Study Completion Date
May 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double-blind, placebo-controlled study with application or not of chronic transcranial direct current stimulation sessions - associated with aerobic exercises - in patients with systemic autoimmune myopathies.
Masking
ParticipantInvestigator
Masking Description
Double-blind study to transcranial direct current stimulation
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
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 cathode will be positioned at contralateral to the dominant limb and the anode 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. The stimulation will happen simultaneously to aerobic exercises for 20 minutes. Total number of stimulation associated with aerobic exercise sessions: 10
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will not receive a transcranial direct current stimulation session. However, the patients will do aerobic exercises for 20 minutes. Total number of sham-stimulation associated with aerobic exercise sessions: 10
Intervention Type
Other
Intervention Name(s)
Chronic transcranial direct current stimulation
Intervention Description
Chronic transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Frequency of treatment-emergent advser events
Description
Frequency of disease relapses (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time Frame
After 30 minutes of intervention
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration)
Time Frame
Before stimulation
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Time Frame
Immediately after all stimulation section
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Time Frame
After 30 days after last stimulation section
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Time Frame
After 60 days after last stimulation section
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Time Frame
After 90 days after last stimulation section
Title
Frequency of treatment-emergent adverse events [safety and tolerability]
Description
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Time Frame
After 300 days after last stimulation section
Secondary Outcome Measure Information:
Title
Myositis Disease Activity Assessment Visual Analogue Scales (MYOACT)
Description
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
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Serum levels of Muscle enzymes
Description
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
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Health Assessment Questionnaire (HAQ)
Description
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Time Frame
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Manual Muscle Testing (MMT)
Description
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
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Patient Global Activity
Description
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
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Physician Global Activity
Description
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)
Time Frame
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Fatigue Severity Scale
Description
The questionnaire offers general fatigue scored by the patients, from 0 (better) to 10 (worse).
Time Frame
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)
Description
The questionnaire offers general pain scored by the patients, from 0 (better) to 10 (worse).
Time Frame
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Short Physical Performance Battery (SPPB)
Description
The value ranges from 0 to 4 in different aspects of funcionality. The scores are compared among different periods of intervention (real or sham-stimulation)
Time Frame
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section
Title
Timed up and go test
Description
To determine fall risk and measure the progress of balance, sit to stand and walking (seconds). The duration will be compared to before versus after intervation (real or sham-stimulation). Long duration (worse) versus short duration (better)
Time Frame
Six times: (a) Before stimulation; (b) Immediately after all stimulation section; (c) after 30, 60, 90 and 300 days after last stimulation section

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Yes Participant eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Classification criteria - EULAR/ACR 2017 Classification critera - Connors et al. Exclusion Criteria: Neoplasia Using heart pacemarker Using visceral metalic clips Infections (HIV, HTLV-1, Hepatitis, etc) Pregnance Previous historical of convulsions or epilepsies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel K Shinjo, PhD
Phone
55113061-7176
Email
samuel.shinjo@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Sao Paulo University
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo
Organizational Affiliation
Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel K Shinjo
City
São Paulo
State/Province
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo, PhD
Phone
551130617176
Email
samuel.shinjo@usp.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Chronic Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

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