MyopathyNCT03749538
Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
A study testing Transcranial direct current stimulation session. in people with Myopathy and Neurologic Manifestations, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myopathy, Neurologic Manifestations, ElectroPhys: Myopathy
- What is being tested?
- Transcranial direct current stimulation session.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Classification criteria - EULAR/ACR 2017
- Classification critera - Connors et al.
- Objective muscle limb weakness
Who cannot join
- Neoplasia
- Using heart pacemarker
- Using visceral metalic clips
- Infections (HIV, HTLV-1, Hepatitis, etc)
- Pregnance
- Previous historical of convulsions or epilepsies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sao Paulo University contact
Brazil1 site, 1 recruiting
- Recruiting
Samuel K Shinjo
São Paulo, 01246903
Samuel K Shinjo, 1130617176, samuel.shinjo@gmail.com
About this study
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.
Read the 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.
- Conditions
- Myopathy, Neurologic Manifestations, ElectroPhys: Myopathy
- Being tested
- Transcranial direct current stimulation session.
- Medical subject headings
- Muscular Diseases, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation session.Other
Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation | Experimental | 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. Receives: Other: Transcranial direct current stimulation session. |
| Placebo | Placebo comparator | This group will not receive a transcranial direct current stimulation session. Receives: Other: Transcranial direct current stimulation session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: After 30 minutes of transcranial stimulation.
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)
Measured: After 8 weeks of transcranial stimulation.
Secondary outcomes (6)
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).
Measured: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation.
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.
Measured: 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)
Especific questionnaire (health assessment questionnaire). Pontuaction 0.00 (best) - 3.00 (worst)
Measured: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
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)
Measured: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)
Measured: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
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)
Measured: 4 times: (a) within 30 minutes before; (b) until 30 minutes after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start1 Oct 2018
- Primary completion6 May 2024
- Study completion4 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo
- Investigators
- Samuel K Shinjo, Principal investigator, Universidade de Sao Paulo - Rheumatology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749538
- Sponsor's protocol ID
- MYO-HCFMUSP-06
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2018
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Transcranial Direct Current Stimulation in Patients With Systemic Autoimmune Myopathies
- ClinicalTrials.gov ID
- NCT03749538
- Acronym / sponsor ID
- MYO-HCFMUSP-06
- Conditions
- Myopathy, Neurologic Manifestations, ElectroPhys: Myopathy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 4 Dec 2024 (estimated)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation | Experimental | Other: Transcranial direct current stimulation session.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. |
| Placebo | Placebo comparator | Other: Transcranial direct current stimulation session.This group will not receive a transcranial direct current stimulation session. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Classification criteria - EULAR/ACR 2017
- Classification critera - Connors et al.
- Objective muscle limb weakness
Key exclusion criteria (6 listed)
- Neoplasia
- Using heart pacemarker
- Using visceral metalic clips
- Infections (HIV, HTLV-1, Hepatitis, etc)
- Pregnance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation session.Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session. | Other | Placebo, Transcranial direct current stimulation |
Primary outcome
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)
Frequency of treatment-emergent adverse events [safety and tolerability]
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)
6 secondary outcomes
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.
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.
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
Related trials for Myopathy
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Active, not recruitingPhase 2/3
A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Fibrodysplasia Ossificans Progressiva
Recruiting
Using Personalized Rehabilitation to Reduce Disease and Increase Activity of Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica (PMR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sao Paulo University contact
Samuel K Shinjo principal investigator
Universidade de Sao Paulo - Rheumatology Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation session. in people with Myopathy and Neurologic Manifestations, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samuel K Shinjo (1130617176, samuel.shinjo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of treatment-emergent adverse events [safety and tolerability] (time frame: After 30 minutes of transcranial stimulation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.