- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02574182
Study of Motor Representations in Healthy Subjects and Amnestic MCI (IRMARCHE)
Walking, Brain and Functional Magnetic Resonance Imaging Study of Motor Representations in Healthy Subjects and Amnestic MCI
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pays De La Loire
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Angers, Pays De La Loire, France, 49933
- University Hospital Angers
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- Healthy volunteers over 18 and under 40.
- Healthy volunteers over 60 years.
- MCI patient over 60 years
Description
Inclusion Criteria:
- Obtaining the signature of consent to participation in the study
- Age above 18 years
- Lack dementia as NICDS-ADRDA criteria
- Lack of pre-existing musculoskeletal disorders, regardless of the cause (except MCI).
- Absence of a history of stroke or other cerebrovascular disease with spinal sensorimotor sequelae.
- No cons-indication for performing a brain MRI.
- Witennses, population of young (<40 years)
- Witnesses ,population of older subjects (> 60 years)
- Witnesses Lack of MCI
- MCI patients, criteria MCI criteria according to Dubois
Exclusion Criteria :
- Refusal of MRI.
- Contraindications to brain MRI.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Control subjects under 40 years
Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet
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Brain MRI (Magnetic Resonance Imaging) brain is a painless test that allows to visualize the different brain structures. Korvit, device made up of 2 shoes which reproduces the feeling to go. The Korvit® system appears possible to analyze the activated cerebral zones and to thus try to better understand the operation of the brain during walk. The GAITRite is a carpet for recording the walking operating parameters
Other Names:
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Control subjects over 60 years
Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet
|
Brain MRI (Magnetic Resonance Imaging) brain is a painless test that allows to visualize the different brain structures. Korvit, device made up of 2 shoes which reproduces the feeling to go. The Korvit® system appears possible to analyze the activated cerebral zones and to thus try to better understand the operation of the brain during walk. The GAITRite is a carpet for recording the walking operating parameters
Other Names:
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MCI subjects over 60 years
Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet
|
Brain MRI (Magnetic Resonance Imaging) brain is a painless test that allows to visualize the different brain structures. Korvit, device made up of 2 shoes which reproduces the feeling to go. The Korvit® system appears possible to analyze the activated cerebral zones and to thus try to better understand the operation of the brain during walk. The GAITRite is a carpet for recording the walking operating parameters
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Review and compare mapping cerebral activation in brain MRI
Time Frame: One day
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Review and compare mapping brain activation in healthy about MRI according to age (<40 years and> 60 years) and MCI through the combination of two paradigms: on mechanically simulated by Korvit® boots and imagination the walk.
The primary endpoint is the analysis of fMRI brain mapping in accordance with the different paradigms of acquisition.
The MRI data will be the subject of a specific statistical treatment, via dedicated software, which will be implemented under the control of the investigators who have conducted such an fMRI analysis in previous studies.
Various brain mapping can be established from the data collected.
It may include statistical comparisons between different preselected regions, and different experimental conditions, or correlation studies between brain activation and clinical parameters.
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One day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Review and compare mapping brain activation in healthy subjects and MCI MRI in imagination alone walking.
Time Frame: One day
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Review and compare mapping brain activation in healthy subjects and MCI MRI in imagination alone walking.
the secondary endpoint will be the analysis of spatiotemporal gait parameters
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One day
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Study of differences in terms of activation of brain mapping
Time Frame: One day
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Study of differences in terms of activation of brain mapping between mechanical stimulation task arch simulating the place of the step (pace to 120 steps per minute) and a random mechanical stimulation (not reproducing the place of the pitch) .
the secondary endpoint will be the analysis of spatiotemporal gait parameters
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One day
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study of functional connectivity of sensorimotor cortex obtained by fMRI resting in the subject MCI.
Time Frame: One day
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study of functional connectivity of sensorimotor cortex obtained by fMRI resting in the subject MCI. the secondary endpoint will be the analysis of spatiotemporal gait parameters
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One day
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study of the potential effects on muscle activation, and autonomic nervous system
Time Frame: One day
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study of the potential effects on muscle activation, and autonomic nervous system of plantar mechanical stimulation reproducing walking.
the secondary endpoint will be the analysis of spatiotemporal gait parameters
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One day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Dinomais, MD, UH Angers
Publications and helpful links
General Publications
- Dinomais M, Minassian AT, Tuilier T, Delion M, Wilke M, N'Guyen S, Richard I, Aube C, Menei P. Functional MRI comparison of passive and active movement: possible inhibitory role of supplementary motor area. Neuroreport. 2009 Oct 7;20(15):1351-5. doi: 10.1097/WNR.0b013e328330cd43.
- Beauchet O, Allali G, Berrut G, Hommet C, Dubost V, Assal F. Gait analysis in demented subjects: Interests and perspectives. Neuropsychiatr Dis Treat. 2008 Feb;4(1):155-60. doi: 10.2147/ndt.s2070.
- Rimmer E, Wojciechowska M, Stave C, Sganga A, O'Connell B. Implications of the Facing Dementia Survey for the general population, patients and caregivers across Europe. Int J Clin Pract Suppl. 2005 Mar;(146):17-24. doi: 10.1111/j.1368-504x.2005.00482.x.
- Ogawa S, Lee TM, Nayak AS, Glynn P. Oxygenation-sensitive contrast in magnetic resonance image of rodent brain at high magnetic fields. Magn Reson Med. 1990 Apr;14(1):68-78. doi: 10.1002/mrm.1910140108.
- Beauchet O, Allali G, Launay C, Herrmann FR, Annweiler C. Gait variability at fast-pace walking speed: a biomarker of mild cognitive impairment? J Nutr Health Aging. 2013 Mar;17(3):235-9. doi: 10.1007/s12603-012-0394-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU PROMOTEUR 2014/32
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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