NCT02574182

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2017

Completed
Last Updated

July 12, 2021

Status Verified

July 1, 2021

Enrollment Period

2.2 years

First QC Date

September 18, 2015

Last Update Submit

July 9, 2021

Conditions

Keywords

Mild Cognitive ImpairmentMagnetic Resonance Imaging

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

Radiation: Brain MRI

Control subjects over 60 years

Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet

Radiation: Brain MRI

MCI subjects over 60 years

Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet

Radiation: Brain MRI

Interventions

Brain MRIRADIATION

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

Also known as: KORVIT, GAITRite
Control subjects over 60 yearsControl subjects under 40 yearsMCI subjects over 60 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* 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

Location

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: 19734813BACKGROUND
  • 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.

    PMID: 18728766BACKGROUND
  • 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.

    PMID: 15801187BACKGROUND
  • 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.

    PMID: 2161986BACKGROUND
  • 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.

    PMID: 23459976BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Michael Dinomais, MD

    UH Angers

    PRINCIPAL INVESTIGATOR

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

Locations