HealthyARTHEMIRS2NCT05743647
Study of Cerebral Activation During Different Rehabilitation Tasks of Lower Limb in Virtual Mirror Therapy in Healthy Subjects
An observational study of Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Observation (OBS), Observation and imagination (OBS-IM) and Observation and realization (OBS-REAL)
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2023to 14 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Right handed healthy subjects aged between 18 and 75 years
Who may be able to join
- 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)
Who cannot join
- Minor subjects
- Adults under guardianship
- Adults under guardianship
- Pregnant or breastfeeding women
- Subjects who have objected to participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Brain Activation With Different Mirror Therapy Tasks - Contribution of EEG and fNIRS 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.
Read the 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
- Conditions
- Healthy
- Being tested
- Observation (OBS), Observation and imagination (OBS-IM), Observation and realization (OBS-REAL)
- Keywords
- Virtual Mirror therapy, Electroencephalography, Near infrared spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Young | 40 right handed healthy subject aged between 18 and 40 Receives: Device: Observation (OBS); Device: Observation and imagination (OBS-IM); Device: Observation and realization (OBS-REAL) | |
| Old | 40 right handed healthy subject aged between 41 and 75 Receives: Device: Observation (OBS); Device: Observation and imagination (OBS-IM); Device: Observation and realization (OBS-REAL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Change in the beta band after movement (Beta-Rebound).
Beta Rebound power in dB normalized to a baseline before the movement.
Measured: Day 0
Secondary outcomes (2)
Mean change in the concentration of oxyhemoglobin during the task
Changes in the concentration of oxyhemoglobin during the task measured with Fnirs device
Measured: Day 0
Mean change in the concentration of deoxyhemoglobin during the task
Changes in the concentration of deoxyhemoglobin during the task measured with Fnirs device
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start20 Feb 2023
- Primary completion14 Apr 2023
- Study completion14 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, Pr, Principal investigator, CHU de Saint Etienne - Hôpital Bellevue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743647
- Sponsor's protocol ID
- CHRO-2022-06
- Acronym
- ARTHEMIRS2
- Status last verified
- Jul 2023
- First submitted
- 15 Feb 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30194016Bonnal 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.
PubMed 35898041Borges 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.
PubMed 30380586Coll 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.
PubMed 28559380Fox 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.
PubMed 26689088Macuga 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.
PubMed 22005592Adham A, Le BT, Bonnal J, Bessaguet H, Ojardias E, Giraux P, Auzou P. Neural basis of lower-limb visual feedback therapy: an EEG study in healthy subjects. J Neuroeng Rehabil. 2024 Jul 8;21(1):114. doi: 10.1186/s12984-024-01408-8.
PubMed 38978051
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Brain Activation With Different Mirror Therapy Tasks - Contribution of EEG and fNIRS in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05743647
- Acronym / sponsor ID
- ARTHEMIRS2 / CHRO-2022-06
- Conditions
- Healthy
- Keywords
- Virtual Mirror therapy, Electroencephalography, Near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 14 Apr 2023 (actual)
- Study completion
- 14 Apr 2023 (actual)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young | – | Device: Observation (OBS), Device: Observation and imagination (OBS-IM), Device: Observation and realization (OBS-REAL)40 right handed healthy subject aged between 18 and 40 |
| Old | – | Device: Observation (OBS), Device: Observation and imagination (OBS-IM), Device: Observation and realization (OBS-REAL)40 right handed healthy subject aged between 41 and 75 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Right handed healthy subjects aged between 18 and 75 years
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- Minor subjects
- Adults under guardianship
- Adults under guardianship
- Pregnant or breastfeeding women
- Subjects who have objected to participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Old, Young |
| 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. | Device | Old, Young |
| 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 | Device | Old, Young |
Primary outcome
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.
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.
2 secondary outcomes
Mean change in the concentration of oxyhemoglobin during the task
Time frame: Day 0
Mean change in the concentration of deoxyhemoglobin during the task
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Background: PubMed 30194016Bartur 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.
- Background: PubMed 35898041Bonnal 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.
- Background: PubMed 30380586Borges 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.
- Background: PubMed 28559380Coll 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.
- Background: PubMed 26689088Fox 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.
- Background: PubMed 22005592Macuga 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.
- Derived from this study: PubMed 38978051Adham A, Le BT, Bonnal J, Bessaguet H, Ojardias E, Giraux P, Auzou P. Neural basis of lower-limb visual feedback therapy: an EEG study in healthy subjects. J Neuroeng Rehabil. 2024 Jul 8;21(1):114. doi: 10.1186/s12984-024-01408-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascal GIRAUX, Pr principal investigator
CHU de Saint Etienne - Hôpital Bellevue
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the EEG spectral alpha and beta-band power (8-12 and 12-30Hz) during movement (Event related Desynchronisation) (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05743647, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.