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
1 other identifier
observational
97
1 country
1
Brief Summary
Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
October 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 13, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2017
CompletedJuly 12, 2021
July 1, 2021
2.2 years
September 18, 2015
July 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Review and compare mapping cerebral activation in brain MRI
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.
One day
Secondary Outcomes (4)
Review and compare mapping brain activation in healthy subjects and MCI MRI in imagination alone walking.
One day
Study of differences in terms of activation of brain mapping
One day
study of functional connectivity of sensorimotor cortex obtained by fMRI resting in the subject MCI.
One day
study of the potential effects on muscle activation, and autonomic nervous system
One day
Study Arms (3)
Control subjects under 40 years
Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet
Control subjects over 60 years
Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet
MCI subjects over 60 years
Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet
Interventions
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
Eligibility Criteria
* Healthy volunteers over 18 and under 40. * Healthy volunteers over 60 years. * MCI patient over 60 years
You may qualify if:
- 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
You may not qualify if:
- Refusal of MRI.
- Contraindications to brain MRI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Angers
Angers, Pays de la Loire Region, 49933, France
Related Publications (5)
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.
PMID: 19734813BACKGROUNDBeauchet 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.
PMID: 18728766BACKGROUNDRimmer 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.
PMID: 15801187BACKGROUNDOgawa 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.
PMID: 2161986BACKGROUNDBeauchet 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.
PMID: 23459976BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Dinomais, MD
UH Angers
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2015
First Posted
October 12, 2015
Study Start
February 24, 2015
Primary Completion
May 13, 2017
Study Completion
May 13, 2017
Last Updated
July 12, 2021
Record last verified: 2021-07