Mild Cognitive Impairment Clinical Trial
— IRMARCHEOfficial title:
Walking, Brain and Functional Magnetic Resonance Imaging Study of Motor Representations in Healthy Subjects and Amnestic MCI
Verified date | July 2021 |
Source | University Hospital, Angers |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI.
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. |
Country | Name | City | State |
---|---|---|---|
France | University Hospital Angers | Angers | Pays De La Loire |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Angers |
France,
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
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 KorvitĀ® 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 |
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