HealthyNCT02001675
Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy
A study testing magnetic resonance imaging (MRI) and 31-phosphorous magnetic resonance spectroscopy (MRS-P31) in people with Healthy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring, maintaining and/or enhancing muscular performance. From a practical point of view, NMES can elicit contractions either by direct activation of motor axons (i.e. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- magnetic resonance imaging (MRI) and 31-phosphorous magnetic resonance spectroscopy (MRS-P31)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jun 2016
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age included between 18 and 45 years
- The volunteers will have to benefit from a social security cover.
- The selected subjects will have to be unhurt of any general disease, psychiatric disorders and any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology.
- They will have to follow no chronic treatment and will have to be unhurt of any history of alcoholism or drug addiction.
Who cannot join
- Usual contraindications for an examination MRI.
- So, will not be included, the subjects:
- suffering from claustrophobia,
- having stimulating one cardiac, carriers of a system Holter,
- carriers of hook(staple) (clip) surgical metallic,
- Carriers of a prosthesis or a metallic implant (or quite different metallic foreign bodies),
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- carriers of a prosthesis dental (device),
- carriers of a hearing aid,
- carriers of an insulin pump,
- having been hurt by pieces of shrapnel or lead,
- Having had a dislocation, a fracture or a recent surgical operation (less than 6 months before the inclusion),
- Having followed a treatment(processing) with anti-inflammatory drugs during the last 3 months, having followed a treatment(processing) with amino acids during 3
Trial locations and contacts
1 site in 1 country.
About this study
Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring, maintaining and/or enhancing muscular performance. From a practical point of view, NMES can elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or by the recruitment of motoneurons in the spinal cord through the depolarization of sensory axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance between transmission along these two pathways. Conventional NMES is usually delivered using short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus intensities so that the large antidromic volley in motor axons ensures that the evoked contraction will be driven largely by the direct depolarization of motor axons beneath the stimulation site with no or little involvement of central nervous system. On the contrary, when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz) (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the corresponding force (recently referred to as "extra force") is significantly (three times) larger than the conventional NMES-induced force. This extra force is supposed to represent the central contribution from the recruitment of spinal motoneurons by the evoked afferent volley given that no additional force was observed during a complete anesthetic block of the nerve proximal to the stimulation site. Despite the obvious differences in terms of activation of the neuromuscular system between conventional and WP-HF NMES, the functional, metabolic and cortical responses associated to both protocols remain to be determined
Read the detailed description
The main goal of the project will be to characterize the evoked-force profile during conventional and WP-HF NMES.
The secondary purpose will be to i) investigate the anatomic and metabolic responses of the human calf muscle following both NMES protocols by using magnetic resonance imaging (MRI) and 31-phosphorous magnetic resonance spectroscopy (MRS-P31), ii) study the cortical responses for both conditions of stimulation by means of functional MRI (f-MRI).
- Conditions
- Healthy
- Being tested
- magnetic resonance imaging (MRI), 31-phosphorous magnetic resonance spectroscopy (MRS-P31)
- Keywords
- Neuromuscular electrical stimulation (NMES)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imaging (MRI)Device
31-phosphorous magnetic resonance spectroscopy (MRS-P31)Device
| Study group | Role | What they receive |
|---|---|---|
| Volunteer healthy | Experimental | Not described Receives: Device: magnetic resonance imaging (MRI); Device: 31-phosphorous magnetic resonance spectroscopy (MRS-P31) |
What is being measured
The primary outcome is the main question the study is designed to answer.
RMI
Assessment of muscle function or brain
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- michele DAMON, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001675
- Sponsor's protocol ID
- 2012-A01265-38
- Other IDs
- 2012-32
- Status last verified
- Nov 2013
- First submitted
- 21 Dec 2012
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy
- ClinicalTrials.gov ID
- NCT02001675
- Acronym / sponsor ID
- 2012-A01265-38
- Conditions
- Healthy
- Keywords
- Neuromuscular electrical stimulation (NMES)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 5 Dec 2013 (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.
Neuromuscular electrical stimulation (NMES) has emerged as a suitable tool for restoring, maintaining and/or enhancing muscular performance. From a practical point of view, NMES can elicit contractions either by direct activation of motor axons (i.e. peripheral mechanism) or by the recruitment of motoneurons in the spinal cord through the depolarization of sensory axons (central mechanism). It is noteworthy that NMES parameters widely affect the balance between transmission along these two pathways. Conventional NMES is usually delivered using short pulse duration (0.05-0.4 ms), low stimulation frequency (15-40 Hz) and high stimulus intensities so that the large antidromic volley in motor axons ensures that the evoked contraction will be driven largely by the direct depolarization of motor axons beneath the stimulation site with no or little involvement of central nervous system. On the contrary, when NMES is delivered using wide pulse widths (1 ms) and high frequency (up to 100 Hz) (WP-HF NMES), a portion of the evoked contraction arises from a central mechanism and the corresponding force (recently referred to as "extra force") is significantly (three times) larger than the conventional NMES-induced force. This extra force is supposed to represent the central contribution from the recruitment of spinal motoneurons by the evoked afferent volley given that no additional force was observed during a complete anesthetic block of the nerve proximal to the stimulation site. Despite the obvious differences in terms of activation of the neuromuscular system between conventional and WP-HF NMES, the functional, metabolic and cortical responses associated to both protocols remain to be determined
Detailed description
The main goal of the project will be to characterize the evoked-force profile during conventional and WP-HF NMES.
The secondary purpose will be to i) investigate the anatomic and metabolic responses of the human calf muscle following both NMES protocols by using magnetic resonance imaging (MRI) and 31-phosphorous magnetic resonance spectroscopy (MRS-P31), ii) study the cortical responses for both conditions of stimulation by means of functional MRI (f-MRI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteer healthy | Experimental | Device: magnetic resonance imaging (MRI), Device: 31-phosphorous magnetic resonance spectroscopy (MRS-P31) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age included between 18 and 45 years
- The volunteers will have to benefit from a social security cover.
- The selected subjects will have to be unhurt of any general disease, psychiatric disorders and any infectious, inflammatory, tumoral, vascular, degenerative or traumatic pathology.
- They will have to follow no chronic treatment and will have to be unhurt of any history of alcoholism or drug addiction.
Key exclusion criteria (12 listed)
- Usual contraindications for an examination MRI.
- suffering from claustrophobia,
- having stimulating one cardiac, carriers of a system Holter,
- carriers of hook(staple) (clip) surgical metallic,
- Carriers of a prosthesis or a metallic implant (or quite different metallic foreign bodies),
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 |
|---|---|---|
| magnetic resonance imaging (MRI) | Device | Volunteer healthy |
| 31-phosphorous magnetic resonance spectroscopy (MRS-P31) | Device | Volunteer healthy |
Primary outcome
RMI
Time frame: 36 months
Assessment of muscle function or brain
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.
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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.
michele DAMON study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging (MRI) and 31-phosphorous magnetic resonance spectroscopy (MRS-P31) in people with Healthy, run by Assistance Publique Hopitaux De Marseille 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 5 Dec 2013. 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. 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?
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?
RMI (time frame: 36 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 5 Dec 2013.