- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05428917
Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb in Healthy Subjects (Lateralinirs)
Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb Using fNIRS Technology in Healthy Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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 the performance of different motor tasks according to the laterality of the task and the subject.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
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 the performance of different motor tasks according to the laterality of the task and the subject.
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 25 minutes, it begins with a rest period of 120 seconds, which corresponds to the baseline. Four different tasks are performed during the acquisition for each subject:
- Simple task right hand (SD)
- Simple task left hand (SG)
- Complex task right hand (CD)
- Complex stain left hand (CG)
The design is a block design, each task, which has a duration of 20 seconds, is carried out 8 times per acquisition. There is therefore a total of 32 tasks whose order will be randomized.
For simple tasks, movements are performed at a frequency of 0.5 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.
Instructions are given verbally at the start of each phase. 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Orléans, France, 45067
- Regional Hospital center of ORLEANS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subject from 18 to 60 years old
- Sufficient command of the French language to understand the instructions
- No known neurological medical history
- Benefiting from social security coverage
- For right-handed subjects: Edinburgh laterality test QL> 40
- For left-handed subjects: Edinburgh laterality test QL< -40
Exclusion Criteria:
- Known allergy to components of the fNIRS device : neoprene
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Near infrared 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.
|
The subject is seated on a chair facing a table, both hands resting on the table. The subject is asked, for each block of 20 seconds, to perform flexion / extension movements of the fingers of the left hand at 0.5 Hz. The subject is seated on a chair facing a table, both hands resting on the table. The subject is asked, for each block of 20 seconds, to perform an exercise based on the nine hole peg test |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Laterality index using t values
Time Frame: Minutes 25
|
Compare the asymmetry of activation of the sensorimotor cortex during a complex motor task on the dominant side between right-handers and left-handers.
|
Minutes 25
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
concentration of oxyhemoglobin measured with fnirs device
Time Frame: Minutes 25
|
Assess the effect of task complexity and the effect of using the dominant or non-dominant side
|
Minutes 25
|
|
concentration of deoxyhemoglobin measured with fnirs device
Time Frame: minutes 25
|
Assess the effect of task complexity and the effect of using the dominant or non-dominant side
|
minutes 25
|
Collaborators and Investigators
Investigators
- Principal Investigator: Julien BONNAL, Regional Hospital center of ORLEANS
Publications and helpful links
General Publications
- Oldfield RC. The assessment and analysis of handedness: the Edinburgh inventory. Neuropsychologia. 1971 Mar;9(1):97-113. doi: 10.1016/0028-3932(71)90067-4. No abstract available.
- Bartur G, Pratt H, Dickstein R, Frenkel-Toledo S, Geva A, Soroker N. Electrophysiological manifestations of mirror visual feedback during manual movement. Brain Res. 2015 May 5;1606:113-24. doi: 10.1016/j.brainres.2015.02.029. Epub 2015 Feb 23.
- Bondi D, Prete G, Malatesta G, Robazza C. Laterality in Children: Evidence for Task-Dependent Lateralization of Motor Functions. Int J Environ Res Public Health. 2020 Sep 15;17(18):6705. doi: 10.3390/ijerph17186705.
- Harris JE, Eng JJ. Individuals with the dominant hand affected following stroke demonstrate less impairment than those with the nondominant hand affected. Neurorehabil Neural Repair. 2006 Sep;20(3):380-9. doi: 10.1177/1545968305284528.
- Ludemann-Podubecka J, Bosl K, Theilig S, Wiederer R, Nowak DA. The Effectiveness of 1 Hz rTMS Over the Primary Motor Area of the Unaffected Hemisphere to Improve Hand Function After Stroke Depends on Hemispheric Dominance. Brain Stimul. 2015 Jul-Aug;8(4):823-30. doi: 10.1016/j.brs.2015.02.004. Epub 2015 Mar 16.
- Duboc V, Dufourcq P, Blader P, Roussigne M. Asymmetry of the Brain: Development and Implications. Annu Rev Genet. 2015;49:647-72. doi: 10.1146/annurev-genet-112414-055322. Epub 2015 Oct 6.
- Grabowska A, Gut M, Binder M, Forsberg L, Rymarczyk K, Urbanik A. Switching handedness: fMRI study of hand motor control in right-handers, left-handers and converted left-handers. Acta Neurobiol Exp (Wars). 2012;72(4):439-51.
- Jin SH, Lee SH, Yang ST, An J. Hemispheric asymmetry in hand preference of right-handers for passive vibrotactile perception: an fNIRS study. Sci Rep. 2020 Aug 7;10(1):13423. doi: 10.1038/s41598-020-70496-y.
- Kim SG, Ashe J, Hendrich K, Ellermann JM, Merkle H, Ugurbil K, Georgopoulos AP. Functional magnetic resonance imaging of motor cortex: hemispheric asymmetry and handedness. Science. 1993 Jul 30;261(5121):615-7. doi: 10.1126/science.8342027.
- Lee SH, Jin SH, An J. The difference in cortical activation pattern for complex motor skills: A functional near- infrared spectroscopy study. Sci Rep. 2019 Oct 1;9(1):14066. doi: 10.1038/s41598-019-50644-9.
- O'Regan L, Serrien DJ. Individual Differences and Hemispheric Asymmetries for Language and Spatial Attention. Front Hum Neurosci. 2018 Oct 4;12:380. doi: 10.3389/fnhum.2018.00380. eCollection 2018.
- Solodkin A, Hlustik P, Noll DC, Small SL. Lateralization of motor circuits and handedness during finger movements. Eur J Neurol. 2001 Sep;8(5):425-34. doi: 10.1046/j.1468-1331.2001.00242.x.
- Vingerhoets G, Acke F, Alderweireldt AS, Nys J, Vandemaele P, Achten E. Cerebral lateralization of praxis in right- and left-handedness: same pattern, different strength. Hum Brain Mapp. 2012 Apr;33(4):763-77. doi: 10.1002/hbm.21247. Epub 2011 Apr 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHRO-2021-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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