Primary Disease Facioscapulohumeral Dystrophy (FSHD)NEMS and FSHDNCT02861911
Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controled Clinical Trial
A study testing Current flow between sensory and motor threshold and Current intensity upper of motor threshold by Kneehab XP technology in people with Primary Disease Facioscapulohumeral Dystrophy (FSHD), run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Disease Facioscapulohumeral Dystrophy (FSHD)
- What is being tested?
- Current flow between sensory and motor threshold and Current intensity upper of motor threshold by Kneehab XP technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2015to Jul 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controlled Clinical Trial
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.
Read the 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.
- Being tested
- Current flow between sensory and motor threshold, Current intensity upper of motor threshold by Kneehab XP technology
- Keywords
- Muscle function, Oxidative stress, Quality of life, Physical activities
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current flow between sensory and motor thresholdOther
Artificial strength training by means of neuromuscular electrical stimulation (NMES)
Current intensity upper of motor threshold by Kneehab XP technologyDevice
Artificial strength training by means of neuromuscular electrical stimulation (NMES)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | The current intensity is generally defined between the sensory and motor threshold (patients feel the power but no visible muscle contraction will be obtained). Receives: Other: Current flow between sensory and motor threshold |
| Active NMES group | Active comparator | 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). Receives: Device: Current intensity upper of motor threshold by Kneehab XP technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal voluntary contraction (MVC) strength of the quadriceps
Measured: At 3 months
Secondary outcomes (5)
Effect of NEMS on the quality of life (SF36 questionnaire)
Measured: At 3 months
Effect of NMES on the quadriceps endurance evaluated in a dynamic test against a charge equal to 30% of maximal isometric force.
Measured: At 3 months
Evaluation of the body composition by bioelectric impedance analysis (BIA) after NMES effect
Measured: At 3 months
Effect of NMES on the bone mineral density by dual energy X-ray absorptiometry (DEXA)
Measured: At 3 months
Effect of NMES on the oxidative stress markers in blood and urine by blood and urine tests
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start20 Oct 2015
- Primary completion13 Sep 2016
- Study completionJul 2018
Why it stopped: Difficulty in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Disease Facioscapulohumeral Dystrophy (FSHD)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861911
- Sponsor's protocol ID
- UF 9344
- Acronym
- NEMS and FSHD
- Status last verified
- May 2019
- First submitted
- 3 Aug 2016
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NMES on Muscle Function of Patients With FSHD: a Double-blind Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02861911
- Acronym / sponsor ID
- NEMS and FSHD / UF 9344
- Keywords
- Muscle function, Oxidative stress, Quality of life, Physical activities
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruiting patients
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 10 Aug 2016 (estimated)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: Current flow between sensory and motor thresholdThe current intensity is generally defined between the sensory and motor threshold (patients feel the power but no visible muscle contraction will be obtained). |
| Active NMES group | Active comparator | Device: Current intensity upper of motor threshold by Kneehab XP technologyTthe 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Current flow between sensory and motor thresholdArtificial strength training by means of neuromuscular electrical stimulation (NMES) | Other | Control group |
| Current intensity upper of motor threshold by Kneehab XP technologyArtificial strength training by means of neuromuscular electrical stimulation (NMES) | Device | Active NMES group |
Primary outcome
Maximal voluntary contraction (MVC) strength of the quadriceps
Time frame: At 3 months
5 secondary outcomes
Effect of NEMS on the quality of life (SF36 questionnaire)
Time frame: At 3 months
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
Evaluation of the body composition by bioelectric impedance analysis (BIA) after NMES effect
Time frame: At 3 months
Effect of NMES on the bone mineral density by dual energy X-ray absorptiometry (DEXA)
Time frame: At 3 months
Effect of NMES on the oxidative stress markers in blood and urine by blood and urine tests
Time frame: At 3 months
Results and safety
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
Related trials for Primary Disease Facioscapulohumeral Dystrophy (FSHD)
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current flow between sensory and motor threshold and Current intensity upper of motor threshold by Kneehab XP technology in people with Primary Disease Facioscapulohumeral Dystrophy (FSHD), run by University Hospital, Montpellier at 1 site in France.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 9 May 2019. 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 France. 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?
The study was stopped early (reason given: Difficulty in recruiting patients). Results are not available in the source record.
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?
Maximal voluntary contraction (MVC) strength of the quadriceps (time frame: At 3 months). 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 9 May 2019.