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Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controled Clinical Trial (NEMS and FSHD)

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ClinicalTrials.gov Identifier: NCT02861911
Recruitment Status : Unknown
Verified August 2016 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
Facioscapulohumeral muscular dystrophy (FSHD) is an autosomal dominant disease characterized by progressive weakness and atrophy of specific skeletal muscles. One of the major problems of patients affected by FSHD is the limitation in performing daily activities induced by the progressive muscle weakness. This sedentary lifestyle can cause a "debilitative cycle," and neuromuscular deconditioning can even aggravate the muscular deficiencies. Recent studies have indicated the safety and the effectiveness of moderate aerobic training programs in patients with FSHD. However, these training programs have limited applicability in patients with more severe muscular weakness. Artificial strength training by means of neuromuscular electrical stimulation (NMES) appears to be a promising rehabilitation strategy for FSHD patients suffering from neuromuscular disorders. Therefore we propose to investigate the feasibility, safety, and effectiveness of NMES strength training to counteract quadriceps muscle weakness in patients affected by FSHD.

Condition or disease Intervention/treatment Phase
Primary Disease Facioscapulohumeral Dystrophy (FSHD) Other: Current flow between sensory and motor threshold Device: Current intensity upper of motor threshold by Kneehab XP technology Not Applicable

Detailed Description:
NMES will be delivered to both quadriceps by means of a Kneehab® XP device, which is an innovative and clinically-proven garment-based product designed specifically to treat quadriceps muscle atrophy. The main NMES current parameters are: 50-Hz frequency, 100-400 µs pulse duration, 5:10-second on:off time. Each session will last approximately 20 minutes and will be repeated 5 days/week for a total duration of the treatment program of 3 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controlled Clinical Trial
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : July 2018

Arm Intervention/treatment
Sham Comparator: Control group
The current intensity is generally defined between the sensory and motor threshold (patients feel the power but no visible muscle contraction will be obtained).
Other: Current flow between sensory and motor threshold
Artificial strength training by means of neuromuscular electrical stimulation (NMES)

Active Comparator: Active NMES group
Tthe current intensity must always meet and exceed the motor threshold (patients feel the current and quadriceps muscle will contract a visible and quantifiable if possible).
Device: Current intensity upper of motor threshold by Kneehab XP technology
Artificial strength training by means of neuromuscular electrical stimulation (NMES)




Primary Outcome Measures :
  1. Maximal voluntary contraction (MVC) strength of the quadriceps [ Time Frame: At 3 months ]

Secondary Outcome Measures :
  1. Effect of NEMS on the quality of life (SF36 questionnaire) [ Time Frame: At 3 months ]
  2. Effect of NMES on the quadriceps endurance evaluated in a dynamic test against a charge equal to 30% of maximal isometric force. [ Time Frame: At 3 months ]
  3. Evaluation of the body composition by bioelectric impedance analysis (BIA) after NMES effect [ Time Frame: At 3 months ]
  4. Effect of NMES on the bone mineral density by dual energy X-ray absorptiometry (DEXA) [ Time Frame: At 3 months ]
  5. Effect of NMES on the oxidative stress markers in blood and urine by blood and urine tests [ Time Frame: At 3 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Molecular and/or clinical diagnosis for FSHD
  • Vignos scale ≤ 5: Able to walk without help
  • Clinically characterized by quadriceps muscle weakness but with a maximal voluntary contraction (MVC) between 8 and 16 Kg
  • Follow as part of their usual care in the Clinical Physiology Department of the University Hospital of Montpellier
  • Free and informed consent of the patient
  • Patient affiliated or beneficiary of a social security system

Exclusion Criteria:

  • Patient with co-morbidity:pathologies heart, pathologies respiratory, metabolic and endocrine -pathologies, pathologies cancer.
  • Patients treated with drugs could cause muscle side effects or interfere with muscle metabolism.
  • Lesions or skin inflammation at the thighs that can prevent the application of NMES
  • Claustrophobic subject
  • Carrier of intracranial vascular clip, cardiac pacemaker, neurostimulator, cochlear implant, or intraocular metallic foreign
  • Pregnant or nursing women
  • Vulnerable Persons and protected Major or unable to consent
  • Patient in exclusion period relative over another protocol, or for which the annual amount of maximum compensation of € 4,500 has been reached

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): NCT02861911


Contacts
Contact: Jacques Mercier, MD PhD j-mercier@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: Jacques Mercier, MD PhD       j-mercier@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02861911     History of Changes
Other Study ID Numbers: UF 9344
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by University Hospital, Montpellier:
Muscle function
Oxidative stress
Quality of life
Physical activities