Study of Motor Representations in Healthy Subjects and Amnestic MCI (IRMARCHE)

July 9, 2021 updated by: University Hospital, Angers

Walking, Brain and Functional Magnetic Resonance Imaging Study of Motor Representations in Healthy Subjects and Amnestic MCI

Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Review and compare mapping brain activation in Magnetic Resonance Imaging about healthy subjects according to age (<40 years and> 60 years) and MCI through the combination of two paradigms: on mechanically simulated by Korvit® boots and imagination of the walk.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pays De La Loire
      • Angers, Pays De La Loire, France, 49933
        • University Hospital Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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:
  • KORVIT
  • GAITRite
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:
  • KORVIT
  • GAITRite
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:
  • KORVIT
  • GAITRite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Review and compare mapping cerebral activation in brain MRI
Time Frame: One day
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Review and compare mapping brain activation in healthy subjects and MCI MRI in imagination alone walking.
Time Frame: One day
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
One day
Study of differences in terms of activation of brain mapping
Time Frame: One day
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
One day
study of functional connectivity of sensorimotor cortex obtained by fMRI resting in the subject MCI.
Time Frame: One day
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
One day
study of the potential effects on muscle activation, and autonomic nervous system
Time Frame: One day
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
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Dinomais, MD, UH Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2015

Primary Completion (Actual)

May 13, 2017

Study Completion (Actual)

May 13, 2017

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

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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