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

Healthy Clinical Trial

— ARTHEMIRS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05743647
• Other study ID #: CHRO-2022-06
• Status: Completed
• Start date: February 20, 2023
• Est. completion date: April 14, 2023

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Observation (OBS)
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)
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)
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

Locations

Country	Name	City	State
France	CHU de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (6)

Bartur G, Pratt H, Frenkel-Toledo S, Soroker N. Neurophysiological effects of mirror visual feedback in stroke patients with unilateral hemispheric damage. Brain Res. 2018 Dec 1;1700:170-180. doi: 10.1016/j.brainres.2018.09.003. Epub 2018 Sep 5. — View Citation

Bonnal J, Monnet F, Le BT, Pila O, Grosmaire AG, Ozsancak C, Duret C, Auzou P. Relation between Cortical Activation and Effort during Robot-Mediated Walking in Healthy People: A Functional Near-Infrared Spectroscopy Neuroimaging Study (fNIRS). Sensors (Basel). 2022 Jul 25;22(15):5542. doi: 10.3390/s22155542. — View Citation

Borges LR, Fernandes AB, Melo LP, Guerra RO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2018 Oct 31;10(10):CD011887. doi: 10.1002/14651858.CD011887.pub2. — View Citation

Coll MP, Press C, Hobson H, Catmur C, Bird G. Crossmodal Classification of Mu Rhythm Activity during Action Observation and Execution Suggests Specificity to Somatosensory Features of Actions. J Neurosci. 2017 Jun 14;37(24):5936-5947. doi: 10.1523/JNEUROSCI.3393-16.2017. Epub 2017 May 30. — View Citation

Fox NA, Bakermans-Kranenburg MJ, Yoo KH, Bowman LC, Cannon EN, Vanderwert RE, Ferrari PF, van IJzendoorn MH. Assessing human mirror activity with EEG mu rhythm: A meta-analysis. Psychol Bull. 2016 Mar;142(3):291-313. doi: 10.1037/bul0000031. Epub 2015 Dec 21. — View Citation

Macuga KL, Frey SH. Neural representations involved in observed, imagined, and imitated actions are dissociable and hierarchically organized. Neuroimage. 2012 Feb 1;59(3):2798-807. doi: 10.1016/j.neuroimage.2011.09.083. Epub 2011 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the EEG spectral alpha and beta-band power (8-12 and 12-30Hz) during movement (Event related Desynchronisation)	Beta desynchronization in dB normalized to a baseline before the movement.	Day 0
Primary	Change in the beta band after movement (Beta-Rebound).	Beta Rebound power in dB normalized to a baseline before the movement.	Day 0
Secondary	Mean change in the concentration of oxyhemoglobin during the task	Changes in the concentration of oxyhemoglobin during the task measured with Fnirs device	Day 0
Secondary	Mean change in the concentration of deoxyhemoglobin during the task	Changes in the concentration of deoxyhemoglobin during the task measured with Fnirs device	Day 0