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Completed

NCT Number: NCT05793762

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

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Orléans

Orléans, 45067, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left virtual mirror therapy task

Device

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).

Right virtual mirror therapy task

Device

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).

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Compare the cortical regions involved during the different mirror therapy tasks

    Time frame: Baseline

    visual analog scale.

  2. Compare the feelings of the subjects

    Time frame: Baseline

    visual analog scale.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study 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

Acronym: LARTHEMIRS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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