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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05428917
Other study ID # CHRO-2021-13
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2022
Est. completion date May 6, 2022

Study information

Verified date December 2022
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate the differences in brain activation in healthy subjects during motor tasks, depending on the laterality of the subject, the laterality of the task and the complexity of the task. It seems that the laterality of activation is less marked in left-handed people, when using the non-dominant hand and when performing a complex task. The objective of this study is to highlight profiles of subject and modality of use of the hand with a specific lateralization of cerebral activation.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date May 6, 2022
Est. primary completion date May 6, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Simple task
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.
complex task
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

Locations

Country Name City State
France Regional Hospital Center of ORLEANS Orléans

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Laterality index using t values 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 concentration of oxyhemoglobin measured with fnirs device Assess the effect of task complexity and the effect of using the dominant or non-dominant side Minutes 25
Secondary concentration of deoxyhemoglobin measured with fnirs device Assess the effect of task complexity and the effect of using the dominant or non-dominant side minutes 25
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