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Trial record 19 of 701 for:    Recruiting, Not yet recruiting, Available Studies | "Muscular Diseases"

Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies

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ClinicalTrials.gov Identifier: NCT03751644
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Electrical Remodeling Rheumatic Diseases Myopathy Other: Electrical stimulation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients with systemic autoimmune myopathies will receive or not the periphericalneuromuscular electrical stimulation in thigh muscles
Masking: Single (Investigator)
Masking Description: Patients will be randomized by non-investigator from the present study
Primary Purpose: Other
Official Title: Peripherical Neuromuscular Electrical Stimulation in Systemic Autoimmune Myopathies
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Disorders

Arm Intervention/treatment
Experimental: Electrical stimulation
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.
Other: Electrical stimulation
Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles

No Intervention: Placebo
Patients will not submitted to electrical stimulation.



Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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 ]
    Specific questionnaires to assess the quality of life. Pontuaction: 0.00 (best) - 3.00 (worst)

  2. 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 ]
    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)

  3. 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. Pontuaction: 0 (best) - 10 (worst)

  4. 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 ]
    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)

  5. 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).

  6. 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 ]
    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.

  7. 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 ]
    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.

  8. 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 ]
    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.

  9. 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 ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on self-representation of gender identity.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Classification criteria - EULAR/ACR 2017
  • Classification criteria - Connors et al.
  • Objective muscle limb weakness

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751644


Contacts
Contact: Samuel K Shinjo 1130617176 samuel.shinjo@gmail.com

Locations
Brazil
Samuel K Shinjo Recruiting
Sao Paulo, Brazil, 01246903
Contact: Samuel K Shinjo    1130617176    samuel.shinjo@gmail.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Samuel K Shinjo Universidade de Sao Paulo - Rheumatology Division

Responsible Party: Samuel Katsuyuki Shinjo, PhD, Professor, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03751644     History of Changes
Other Study ID Numbers: MYO-HCFMUSP-07
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samuel Katsuyuki Shinjo, PhD, University of Sao Paulo:
systemic autoimmune myopathies
Peripherical neuromuscular electrical stimulation
myositis

Additional relevant MeSH terms:
Muscular Diseases
Rheumatic Diseases
Collagen Diseases
Atrial Remodeling
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Pathological Conditions, Anatomical
Pathologic Processes