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Completed

NCT Number: NCT05743647

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

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.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Saint-Etienne

Saint-Etienne, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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)

Exclusion criteria

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

Treatment and study plan

Observation (OBS)

Device

Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.

The subject only observe the movement on the screen during the recordings. The subject does not produce any movement.

Observation and imagination (OBS-IM)

Device

Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.

The subject observe the movement but also imagine to realized it.

Observation and realization (OBS-REAL)

Device

Subject is seated in a chair facing IVS4. He places his right lower under the screen. The flexion / extension movement of the ankle at a frequency of 0.5 Hz is then recorded. Then for the "mirror" effect the software reverses the recorded movement, the lower right limb becomes the lower left limb on the screen.

The subject observe the movement on the screen and realized it

Primary outcomes

  1. Change in the EEG spectral alpha and beta-band power (8-12 and 12-30Hz) during movement (Event related Desynchronisation)

    Time frame: Day 0

    Beta desynchronization in dB normalized to a baseline before the movement.

  2. Change in the beta band after movement (Beta-Rebound).

    Time frame: Day 0

    Beta Rebound power in dB normalized to a baseline before the movement.

Secondary outcomes

  1. Mean change in the concentration of oxyhemoglobin during the task

    Time frame: Day 0

    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: Day 0

    Changes in the concentration of deoxyhemoglobin during the task measured with Fnirs device

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Assessment of Brain Activation With Different Mirror Therapy Tasks - Contribution of EEG and fNIRS in Healthy Subjects.

Acronym: ARTHEMIRS2

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 24, 2023
Registry last updated
Aug 2, 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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