Study of Motor Representations in Healthy Subjects and Amnestic MCI

Mild Cognitive Impairment Clinical Trial

— IRMARCHE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574182
• Other study ID #: CHU PROMOTEUR 2014/32
• Status: Completed
• Start date: February 24, 2015
• Est. completion date: May 13, 2017

Study information

• Verified date: July 2021
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: May 13, 2017
• Est. primary completion date: May 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Radiation:
• Brain MRI
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

Locations

Country	Name	City	State
France	University Hospital Angers	Angers	Pays De La Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

Dinomais M, Minassian AT, Tuilier T, Delion M, Wilke M, N'Guyen S, Richard I, Aubé 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Review and compare mapping brain activation in healthy subjects and MCI MRI in imagination alone walking.	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
Secondary	Study of differences in terms of activation of brain mapping	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
Secondary	study of functional connectivity of sensorimotor cortex obtained by fMRI resting in the subject MCI.	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
Secondary	study of the potential effects on muscle activation, and autonomic nervous system	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