Study of Cerebral Activation During Different Rehabilitation Tasks of Lower Limb in Virtual Mirror Therapy in Healthy Subjects

Completed

• Conditions: Healthy
• Interventions: Device: Observation (OBS); Device: Observation and imagination (OBS-IM); Device: Observation and realization (OBS-REAL)

• Registration Number: NCT05743647
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

Brief Summary

The purpose of this study is to investigate the cerebral activation during visual motor simulation in healthy subjects in 3 conditions: observation (OBS), observation and imagination (OBS-IM) and observation and realization (OBS-REAL). The investigators goal is to compare cerebral activation during the three different tasks using EEG and fNIRS.

Detailed Description

Mirror therapy is a rehabilitation technique that has been shown to be effective in restoring upper limb motor skills in patients with stroke. However, it comes up against certain constraints of clinical use such as installation difficulties or the obligation of symmetrical bilateral work. These constraints can be limited by the use of so-called 2nd generation virtual mirror therapy technologies. It is therefore likely that these new technologies will improve the feasibility and effectiveness of mirror therapy in rehabilitation.

The brain mechanisms involved in virtual mirror therapy are not yet fully understood. EEG (Electroencephalography) and fNIRS (functional Near Infra Red Spectroscopy) are two functional method that allows to study the cerebral cortex changes during different tasks (like fMRI).

These techniques therefore makes it possible to study brain activation under more ecological conditions than fMRI and are therefore particularly suitable for exploring rehabilitation techniques.

This research aims to study and compare in healthy subjects, using EEG and fNIRS, the brain regions involved in three tasks using a virtual mirror therapy device (IVS4 apparatus ; Dessintey, France) implying lower limb control.

The protocol has 3 conditions :

observation (OBS), observation and imagination (OBS-IM) and observation and realization (OBS-REAL).

The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions.

The EEG recording will used the 32 channels ENOBIO apparatus. The fNIRS will used the Brite MKII apparatus

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-15
• Study Start: 2023-02-20
• Study First Posted: 2023-02-24
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Subjects aged 18 to 75 years
• Sufficient command of the French language to understand the instructions
• No known neurological medical history
• With social security coverage
• Right-handed subjects with a laterality test of Edinburgh QL> 40 (Oldfield 1971)

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Exclusion Criteria

• Minor subjects
• Adults under guardianship
• Adults under guardianship
• Pregnant or breastfeeding women
• Subjects who have objected to participating in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Young	Observation (OBS)	40 right handed healthy subject aged between 18 and 40
Young	Observation and imagination (OBS-IM)	40 right handed healthy subject aged between 18 and 40
Old	Observation and imagination (OBS-IM)	40 right handed healthy subject aged between 41 and 75
Young	Observation and realization (OBS-REAL)	40 right handed healthy subject aged between 18 and 40
Old	Observation (OBS)	40 right handed healthy subject aged between 41 and 75
Old	Observation and realization (OBS-REAL)	40 right handed healthy subject aged between 41 and 75

Primary Outcome Measures

Name	Time	Method
Change in the EEG spectral alpha and beta-band power (8-12 and 12-30Hz) during movement (Event related Desynchronisation)	Day 0	Beta desynchronization in dB normalized to a baseline before the movement.
Change in the beta band after movement (Beta-Rebound).	Day 0	Beta Rebound power in dB normalized to a baseline before the movement.

Secondary Outcome Measures

Name	Time	Method
Mean change in the concentration of deoxyhemoglobin during the task	Day 0	Changes in the concentration of deoxyhemoglobin during the task measured with Fnirs device
Mean change in the concentration of oxyhemoglobin during the task	Day 0	Changes in the concentration of oxyhemoglobin during the task measured with Fnirs device

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Étienne, France