Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb in Healthy Subjects (Lateralinirs)

December 27, 2022 updated by: Centre Hospitalier Régional d'Orléans

Evaluation of the Impact of Laterality on Cerebral Activation During a Motor Task of the Upper Limb Using fNIRS Technology in Healthy Subjects

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Orléans, France, 45067
        • Regional Hospital center of ORLEANS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julien BONNAL, Regional Hospital center of ORLEANS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2022

Primary Completion (Actual)

May 6, 2022

Study Completion (Actual)

May 6, 2022

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Estimate)

December 28, 2022

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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