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Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

Primary Purpose

Myopathy, Neurologic Manifestations, ElectroPhys: Myopathy

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct current stimulation session.
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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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 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.

This group will not receive a transcranial direct current stimulation session.

Outcomes

Primary Outcome Measures

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 measures) and tolerability (patients' symptom registration)

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)

Full Information

First Posted
November 16, 2018
Last Updated
May 16, 2023
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03749538
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopathy, Neurologic Manifestations, ElectroPhys: 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 a transcranial current stimulation session in patients with systemic autoimmune myopathies.
Masking
ParticipantInvestigator
Masking Description
Double-blind study to transcranial 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 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group will not receive a transcranial direct current stimulation session.
Intervention Type
Other
Intervention Name(s)
Transcranial direct current stimulation session.
Intervention Description
Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
Primary Outcome Measure Information:
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
After 30 minutes of transcranial stimulation.
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
After 8 weeks of transcranial stimulation.
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
3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
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
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
Title
Health Assessment Questionnaire (HAQ)
Description
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Time Frame
3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
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
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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
4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Participant eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel K Shinjo
Phone
1130617176
Email
samuel.shinjo@gmail.com
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
Universidade de Sao Paulo - Rheumatology Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samuel K Shinjo
City
Sao Paulo
ZIP/Postal Code
01246903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel K Shinjo
Phone
1130617176
Email
samuel.shinjo@gmail.com

12. IPD Sharing Statement

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Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies

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