Study of Cerebral Activation During Different Rehabilitation Tasks in Mirror Therapy in Healthy Subjects (ARTHEMIRS)

May 11, 2021 updated by: Centre Hospitalier Régional d'Orléans

ARTHEMIRS: Assessment of Brain Activation During Different Mirror Therapy Tasks Using fNIRS Technology

The purpose of this study is to investigate the cerebral activation during Classic Mirror Therapy (TMC) and especially during Virtual Mirror Therapy (TMV) in healthy subjects. It seems that the precuneus is involved in the effectiveness of mirror therapy. One goal of this study is to determine if there is a better activation of the precuneus during TMV than during TMC. Others goals are to compare cerebral activation during three different tasks (TMV, TMC and a simple motor task), to study the intra-subjects reproducibility of the measurement and the correlation between cerebral activation and feelings of the participants about the efficacity of the tasks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. While the brain mechanisms involved in mirror therapy are not yet fully understood, the involvement of the precuneus has been demonstrated by a booming imaging method: 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 region of the brain increases its local blood flow. Oxygenated hemoglobin (HbO) and deoxygenated (HbR) absorb infrared light and it is then possible to identify the cortical regions of the brain involved in a given task. This technique therefore makes it possible to study brain activation under more ecological conditions than fMRI and is therefore particularly suitable for exploring rehabilitation techniques.

This research aims to study and compare in healthy subjects, using a fNIRS apparatus, the brain regions involved in the performance of a classic mirror therapy task and a virtual mirror therapy task with the IVS3 (Intensive Visual Simulation) apparatus (Dessintey Technology).

The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.

Each acquisition has a duration of 620 seconds, it begins with a rest period of 120 seconds, which corresponds to the baseline.

For each condition the movements are performed at a frequency of 0.5 Hz which seems to be the optimal frequency for observing cortical activation using a metronome. Each movement is therefore performed 10 times per block.

The order of placing the various conditions will be balanced. Between periods of movement, the subject is in a resting position for 30 seconds.

The "movement" and "rest" instructions are given at the start of each phase. The entire test will be repeated one week apart to assess the reproducibility of the measurements in healthy subjects.

The protocol has 3 conditions:

  • A virtual TM task (TMV)
  • A classic TM task (TMC)
  • A control task (TC) Healthy subjects participating in the study will have two different acquisition times, each comprising 3 conditions.

After recruiting the subjects, the study investigator will check the inclusion and non-inclusion criteria.

If the subject can integrate the protocol, the two acquisition stages will then be scheduled one week apart.

On the day of the first acquisition, the subject will present to the neurology department at the time of his appointment.

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

Then the fNIRS acquisition headset (Brite 24) will be installed by a specialized technician and the procurement instructions will be given.

The acquisition under the 3 conditions is then carried out: TC1, TMC1, TMV1 with a rest time of 10 minutes between each condition.

The subject's feelings after the TMC and TMV conditions will be evaluated using the visual analogue scale (VAS). 0 corresponding to a zero feeling and 10 to a very important feeling. The subject will be explained that the feeling could correspond to tingling sensations, a desire to mobilize the hand which is behind the mirror, a "disturbing", "bizarre" sensation.

The helmet is only removed at the end of the 3 spots The subject returns a week later for the 2nd acquisition phase during which the same acquisitions as during the 1st meeting are carried out and then participation in the study is terminated.

There will therefore be 6 tests for each healthy subject.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Orléans, France, 45067
        • CHR Orléans

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

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age:18 to 40
  • Right handed
  • No neurological disease

Exclusion Criteria:

  • 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

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy volunteers
Virtual mirror therapy task : TMV Classic mirror therapy task : TMC Control task :TC
Other: Therapy Mirror task

The protocol has 3 conditions:

  • A virtual TM task (TMV
  • A classic TM task (TMC)
  • A control task (TC)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV)
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the level of activation of the precuneus during TMC and TC.
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device
Day 0
Compare the level of precuneus activation during TMV and TC.
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Day 0
Compare the level of activation of contralateral motor regions to visual feedback during TMC and TMV.
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Day 0
Compare the level of activation of the contralateral motor regions to visual feedback during TMV and TC.
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Day 0
Compare the level of activation of the contralateral motor regions to visual feedback during TMC and TC.
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Day 0
Evaluate the reproducibility of measurements
Time Frame: Day 0
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Day 0
Evaluate the reproducibility of measurements
Time Frame: Day 7
Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs (functional Near Infra Red Spectroscopy) device
Day 7
Compare the cortical regions involved during the different mirror therapy tasks and the feelings of the subjects.
Time Frame: Day 0
Visual Analog Scale (VAS), minimal score is 0 (worst score) maximal score is 10 (better score)
Day 0

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)

February 8, 2021

Primary Completion (Actual)

March 4, 2021

Study Completion (Actual)

March 4, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 12, 2021

Last Update Submitted That Met QC Criteria

May 11, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHRO 2020-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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