Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793762
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2023-03-08
Brief Title:
Evaluation of the Impact of Laterality on Brain Activation During a Virtual Mirror Therapy Task in Healthy Subjects
Sponsor:
Centre Hospitalier Régional dOrléans
Organization:
Centre Hospitalier Régional dOrléans
Study Overview
Official Title:
Evaluation of the Impact of Laterality on Cerebral Activation During a Virtual Mirror Therapy Task of Upper Limb Using fNIRS Technology in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LARTHEMIRS
Brief Summary:
The aim of this study is to investigate the differences in brain activation in healthy subjects during virtual mirror therapy tasks depending on the laterality of the task It seems that mirror therapy-related brain activation is greater when the visual feedback represents the non-dominant hand The aim of this study is to highlight brain activation profiles during the use of virtual mirror therapy according to the lateralization of the feedback
Detailed Description:
Stroke frequently leads to upper limb deficit The recovery of motor skills depends on many factors including laterality The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality An imaging technique is particularly suitable for exploring these different mechanisms fNIRS Functional Near Infra Red Spectroscopy This method allows like fMRI to study cerebral neurovascular coupling It is based on the fact that an activated brain region increases its local blood flow Oxygenated HbO and deoxygenated HbR hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques
This research aims to study and compare in healthy subjects using an fNIRS apparatus the brain regions involved in a virtual mirror therapy task according to the laterality of the task
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department
The acquisition has a duration of 15 minutes it begins with a rest period of 120 seconds which corresponds to the baseline two different tasks are performed during the acquisition for each subject
observation of visual feedback of the right hand RVF
observation of visual feedback of the left hand LVF
The design is a block design each task which has a duration of 20 seconds is carried out 10 times per acquisition There is therefore a total of 20 tasks whose order will be randomized
Before each acquisition the movements of the right and left hands finger flexion and extension are recorded by a camera integrated in the virtual mirror therapy tool Movements are performed at a frequency of 05 Hz which appears to be the optimal frequency for observing cortical activation using a metronome
Between periods of movement the subject is in a rest position for a period from 15 to 25 seconds
The instructions given to each subject are to observe the visual feedback on the screen and not to perform any movement during the acquisition
After recruiting the subjects the study investigator will check the inclusion and exclusion criteria
If the subject can integrate the protocol the acquisition will then be planned
On the day of the acquisition the fNIRS acquisition helmet Brite MKII will be installed by a specialist technician and instructions will be given The recording is then made
This research aims to study and compare in healthy subjects using an fNIRS apparatus the brain regions involved in a virtual mirror therapy task according to the laterality of the task
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department
The acquisition has a duration of 15 minutes it begins with a rest period of 120 seconds which corresponds to the baseline two different tasks are performed during the acquisition for each subject
observation of visual feedback of the right hand RVF
observation of visual feedback of the left hand LVF
The design is a block design each task which has a duration of 20 seconds is carried out 10 times per acquisition There is therefore a total of 20 tasks whose order will be randomized
Before each acquisition the movements of the right and left hands finger flexion and extension are recorded by a camera integrated in the virtual mirror therapy tool Movements are performed at a frequency of 05 Hz which appears to be the optimal frequency for observing cortical activation using a metronome
Between periods of movement the subject is in a rest position for a period from 15 to 25 seconds
The instructions given to each subject are to observe the visual feedback on the screen and not to perform any movement during the acquisition
After recruiting the subjects the study investigator will check the inclusion and exclusion criteria
If the subject can integrate the protocol the acquisition will then be planned
On the day of the acquisition the fNIRS acquisition helmet Brite MKII will be installed by a specialist technician and instructions will be given The recording is then made
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None