Evaluation of the Impact of Laterality on Brain Activation During a Virtual Mirror Therapy Task in Healthy Subjects (LARTHEMIRS)

May 5, 2023 updated by: Centre Hospitalier Régional d'Orléans

Evaluation of the Impact of Laterality on Cerebral Activation During a Virtual Mirror Therapy Task of 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 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.

Study Overview

Status

Completed

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 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 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.

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Contact

Study Locations

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

Yes

Sampling Method

Non-Probability Sample

Study Population

right handed healthy subjects aged between 18 and 60

Description

Inclusion Criteria:

  • Age:18 to 60
  • Right handed
  • No neurological disease

Exclusion Criteria:

  • Person under tutorship or curatorship
  • 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy participants
30 right handed healthy participants aged between 18 and 60.
Device: Left virtual mirror therapy task
the participant is seated on a chair facing the screen of the virtual mirror therapy device. both hands resting under the screen. The participant is asked, for each block of 20 seconds, to observe the visual feedback of the virtual left hand on the screen (flexion / extension movements of the fingers at 0.5 Hz).
Device: Right virtual mirror therapy task
the participant is seated on a chair facing the screen of the virtual mirror therapy device. both hands resting under the screen. The participant is asked, for each block of 20 seconds, to observe the visual feedback of the virtual right hand on the screen (flexion / extension movements of the fingers at 0.5 Hz).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in the concentration of oxyhemoglobin during the task
Time Frame: Baseline
Changes in the concentration of oxyhemoglobin during the task measured with fnirs device
Baseline
Mean change in the concentration of deoxyhemoglobin during the task
Time Frame: Baseline
Changes in the concentration of deoxyhemoglobin during the task measured with fnirs device
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the cortical regions involved during the different mirror therapy tasks
Time Frame: Baseline
visual analog scale.
Baseline
Compare the feelings of the subjects
Time Frame: Baseline
visual analog scale.
Baseline

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Julien BONNAL, CHR d'Orléans

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)

March 9, 2023

Primary Completion (Actual)

March 23, 2023

Study Completion (Actual)

March 23, 2023

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Estimate)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHRO-2022-17

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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