Electrical RemodelingNCT03751644
Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
A study testing Electrical stimulation in people with Electrical Remodeling and Rheumatic Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Electrical Remodeling, Rheumatic Diseases, Myopathy
- What is being tested?
- Electrical stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2018to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 criteria - Connors et al.
- Objective muscle limb weakness
Who cannot join
- Neoplasia
- Using heart pacemarker
- Using visceral metalic clips
- Infections (HIV, HTLV-1, Hepatitis, etc)
- Pregnancy
- Previous historical of convulsions or epilepsies
Trial locations and contacts
1 site in 1 country.
About this study
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases with progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
Read the detailed description
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily affect the skeletal muscles. 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 importance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
- Conditions
- Electrical Remodeling, Rheumatic Diseases, Myopathy
- Being tested
- Electrical stimulation
- Keywords
- systemic autoimmune myopathies, Peripherical neuromuscular electrical stimulation, myositis
- Medical subject headings
- Atrial Remodeling, Rheumatic Diseases, Muscular Diseases, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationOther
Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | After local antisepsis, 4 electrodes will be placed at the proximal and distal extremities of the lateral and vastus medialis muscles of dominant limb. A positive, single-phase pulsating (intermittent) current with a rectangular waveform will be delivered with a duty cycle of 10 to 15 seconds shutdown at a frequency of 60 Hertz with a pulse width of 400 microseconds for 30 minutes. To control the degree of muscle activation, electrical stimulation will be administered at an intensity that will consistently produce a target torque equal to 15% of maximal voluntary contraction, as monitored in real time through torque output. The desired intensity of stimulation and intensity adjustments throughout the treatment will be evaluated in all patients. Receives: Other: Electrical stimulation |
| Placebo | No intervention | Patients will not submitted to electrical stimulation. |
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) electrical stimulation in patients with systemic autoimmune myopathies.
Measured: 30 minutes after stimulation
Frequency of treatment-emergent adverse events [safety and tolerability]
Frequency of disease relapsing (based on the questionnaire of secondary outcome
Measured: 8 weeks after stimulation
Secondary outcomes (9)
Healthy Assessment Questionnaire (HAQ)
Specific questionnaires to assess the quality of life. 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
Patient/Parent 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. 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
Manual Muscle Testing
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
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. International Unit: U/L.
Measured: 4 times: (a) within 30 min before; (b) until 30 min after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Strength muscle tests
The dynamic 1-repetition maximum for the leg-press will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
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
Strength muscle tests
The dynamic 1-repetition maximum for the bench-press exercises will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
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
Strength muscle tests
Isometric strength (assessed by handgrip, with the dominant arm) will be assessed at baseline and after the intervention. Strength unit: Newton (N). The values vary according to each patient.
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 posted23 Nov 2018
- Study start1 Nov 2018
- Primary completion29 Apr 2021
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical RemodelingStudies of the same condition, open and under way.
- 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
- Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6 participants (actual)
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
- NCT03751644
- Sponsor's protocol ID
- MYO-HCFMUSP-07
- Status last verified
- Apr 2021
- First submitted
- 16 Nov 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
- ClinicalTrials.gov ID
- NCT03751644
- Acronym / sponsor ID
- MYO-HCFMUSP-07
- Conditions
- Electrical Remodeling, Rheumatic Diseases, Myopathy
- Keywords
- systemic autoimmune myopathies, Peripherical neuromuscular electrical stimulation, myositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 23 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 with progressive skeletal muscle weakness. The relevance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
Detailed description
Systemic autoimmune myopathies are a heterogeneous group of rheumatic diseases that primarily affect the skeletal muscles. 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 importance of the peripherical neuromuscular electrical stimulation has never applied in the patients with systemic autoimmune myopathies. Therefore, the main objective of the present prospective, randomized, investigator-blind, placebo-controlled study is to evaluate the safety and efficacy of the application of an acute peripherical neuromuscular electrical stimulation session in patients with systemic autoimmune myopathies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Other: Electrical stimulationAfter local antisepsis, 4 electrodes will be placed at the proximal and distal extremities of the lateral and vastus medialis muscles of dominant limb. A positive, single-phase pulsating (intermittent) current with a rectangular waveform will be delivered with a duty cycle of 10 to 15 seconds shutdown at a frequency of 60 Hertz with a pulse width of 400 microseconds for 30 minutes. To control the degree of muscle activation, electrical stimulation will be administered at an intensity that will consistently produce a target torque equal to 15% of maximal voluntary contraction, as monitored in real time through torque output. The desired intensity of stimulation and intensity adjustments throughout the treatment will be evaluated in all patients. |
| Placebo | No intervention | –Patients will not submitted to electrical stimulation. |
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 criteria - 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)
- Pregnancy
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 |
|---|---|---|
| Electrical stimulationPatients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles | Other | Electrical stimulation |
Primary outcome
Frequency of treatment-emergent adverse events [safety and tolerability]
Time frame: 30 minutes after stimulation
Frequency of disease relapsing (based on the questionnaire of secondary outcome measures) and tolerability (patients' symptom registration) electrical stimulation in patients with systemic autoimmune myopathies.
Frequency of treatment-emergent adverse events [safety and tolerability]
Time frame: 8 weeks after stimulation
Frequency of disease relapsing (based on the questionnaire of secondary outcome
9 secondary outcomes
Healthy Assessment Questionnaire (HAQ)
Time frame: 3 times: (a) within 30 minutes before stimulation. Then, after (b) 3 weeks and (c) 8 weeks after stimulation
Patient/Parent 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
Manual Muscle Testing
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
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 min before; (b) until 30 min after stimulation. Then, after (c) 3 weeks and (d) 8 weeks after stimulation
Strength muscle tests
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
Strength muscle tests
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
Strength muscle tests
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Electrical stimulation in people with Electrical Remodeling and Rheumatic Diseases, 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: finished, as of the sponsor's last update on 30 Apr 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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: 30 minutes after 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 30 Apr 2021.