- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001675
Comparison of Both Metabolic and Functional Effects Induced by Two Neuromuscular Electrical Stimulation Protocols: A Comprehensive Approach Using Magnetic Resonance Imaging and Spectroscopy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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),
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Volunteer healthy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RMI
Time Frame: 36 months
|
Assessment of muscle function or brain
|
36 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2012-A01265-38
- 2012-32 (OTHER: AP HM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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