Mild Cognitive ImpairmentIRMARCHENCT02574182
Study of Motor Representations in Healthy Subjects and Amnestic MCI
An observational study of Mild Cognitive Impairment, run by University Hospital, Angers at 1 site in France.
Trial summary
Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Brain MRI
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2015to 13 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Healthy volunteers over 18 and under 40. * Healthy volunteers over 60 years. * MCI patient over 60 years
Who may be able to join
- 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.
Show all 10Show fewer
- 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
Who cannot join
- Refusal of MRI.
- Contraindications to brain MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Brain MRI
- Keywords
- Mild Cognitive Impairment, Magnetic Resonance Imaging
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIRadiation
Also called KORVIT, GAITRite
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
| Study group | Role | What they receive |
|---|---|---|
| Control subjects under 40 years | Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet Receives: Radiation: Brain MRI | |
| Control subjects over 60 years | Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet Receives: Radiation: Brain MRI | |
| MCI subjects over 60 years | Brain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet Receives: Radiation: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (4)
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
Measured: One day
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
Measured: One day
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
Measured: One day
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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study start24 Feb 2015
- Primary completion13 May 2017
- Study completion13 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Michael Dinomais, MD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574182
- Sponsor's protocol ID
- CHU PROMOTEUR 2014/32
- Acronym
- IRMARCHE
- Status last verified
- Jul 2021
- First submitted
- 18 Sep 2015
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19734813Beauchet 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.
PubMed 18728766Rimmer 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.
PubMed 15801187Ogawa 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.
PubMed 2161986Beauchet 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.
PubMed 23459976
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking, Brain and Functional Magnetic Resonance Imaging Study of Motor Representations in Healthy Subjects and Amnestic MCI
- ClinicalTrials.gov ID
- NCT02574182
- Acronym / sponsor ID
- IRMARCHE / CHU PROMOTEUR 2014/32
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 24 Feb 2015 (actual)
- Primary completion
- 13 May 2017 (actual)
- Study completion
- 13 May 2017 (actual)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Walking, Brain and Functional Magnetic Resonance Imaging Study of motor representations in healthy subjects and amnesic MCI.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control subjects under 40 years | – | Radiation: Brain MRIBrain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet |
| Control subjects over 60 years | – | Radiation: Brain MRIBrain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet |
| MCI subjects over 60 years | – | Radiation: Brain MRIBrain MRI Simulated walking with Corvit boots Records gait parameters on Gaitrite carpet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Healthy volunteers over 18 and under 40. * Healthy volunteers over 60 years. * MCI patient over 60 years
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- Refusal of MRI.
- Contraindications to brain MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIAlso: KORVIT, GAITRiteBrain 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 | Radiation | Control subjects over 60 years, Control subjects under 40 years, MCI subjects over 60 years |
Primary outcome
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.
4 secondary outcomes
Review and compare mapping brain activation in healthy subjects and MCI MRI in imagination alone walking.
Time frame: One day
Study of differences in terms of activation of brain mapping
Time frame: One day
study of functional connectivity of sensorimotor cortex obtained by fMRI resting in the subject MCI.
Time frame: One day
study of the potential effects on muscle activation, and autonomic nervous system
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Background: PubMed 19734813Dinomais 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.
- Background: PubMed 18728766Beauchet 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.
- Background: PubMed 15801187Rimmer 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.
- Background: PubMed 2161986Ogawa 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.
- Background: PubMed 23459976Beauchet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Dinomais, MD principal investigator
UH Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Review and compare mapping cerebral activation in brain MRI (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574182, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.