HealthyLARTHEMIRSNCT05793762
Evaluation of the Impact of Laterality on Brain Activation During a Virtual Mirror Therapy Task in Healthy Subjects
An observational study of Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The aim of this study is to investigate the differences in brain activation in healthy subjects during virtual mirror therapy tasks, depending on the laterality of the task. It seems that mirror therapy-related brain activation is greater when the visual feedback represents the non-dominant hand. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Left virtual mirror therapy task and Right virtual mirror therapy task
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2023to 23 Mar 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: right handed healthy subjects aged between 18 and 60
Who may be able to join
- Age:18 to 60
- Right handed
- No neurological disease
Who cannot join
- Person under tutorship or curatorship
- Known allergy to components of the fNIRS device: neoprene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of Laterality on Cerebral Activation During a Virtual Mirror Therapy Task of Upper Limb Using fNIRS Technology in Healthy Subjects
The aim of this study is to investigate the differences in brain activation in healthy subjects during virtual mirror therapy tasks, depending on the laterality of the task. It seems that mirror therapy-related brain activation is greater when the visual feedback represents the non-dominant hand. The aim of this study is to highlight brain activation profiles during the use of virtual mirror therapy according to the lateralization of the feedback.
Read the detailed description
Stroke frequently leads to upper limb deficit. The recovery of motor skills depends on many factors including laterality. The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not. These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality. An imaging technique is particularly suitable for exploring these different mechanisms: 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 brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using an fNIRS apparatus, the brain regions involved in a virtual mirror therapy task according to the laterality of the task.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
The acquisition has a duration of 15 minutes, it begins with a rest period of 120 seconds, which corresponds to the baseline. two different tasks are performed during the acquisition for each subject:
- observation of visual feedback of the right hand (RVF)
- observation of visual feedback of the left hand (LVF)
The design is a block design, each task, which has a duration of 20 seconds, is carried out 10 times per acquisition. There is therefore a total of 20 tasks whose order will be randomized.
Before each acquisition, the movements of the right and left hands (finger flexion and extension) are recorded by a camera integrated in the virtual mirror therapy tool. Movements are performed at a frequency of 0.5 Hz which appears to be the optimal frequency for observing cortical activation using a metronome.
Between periods of movement, the subject is in a rest position for a period from 15 to 25 seconds.
The instructions given to each subject are to observe the visual feedback on the screen and not to perform any movement during the acquisition.
After recruiting the subjects, the study investigator will check the inclusion and exclusion criteria.
If the subject can integrate the protocol, the acquisition will then be planned.
On the day of the acquisition, the fNIRS acquisition helmet (Brite MKII) will be installed by a specialist technician and instructions will be given. The recording is then made.
- Conditions
- Healthy
- Being tested
- Left virtual mirror therapy task, Right virtual mirror therapy task
- Keywords
- mirror therapy, laterality, cortical activation, functional near-infrared spectroscopy, upper limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left virtual mirror therapy taskDevice
the participant is seated on a chair facing the screen of the virtual mirror therapy device. both hands resting under the screen. The participant is asked, for each block of 20 seconds, to observe the visual feedback of the virtual left hand on the screen (flexion / extension movements of the fingers at 0.5 Hz).
Right virtual mirror therapy taskDevice
the participant is seated on a chair facing the screen of the virtual mirror therapy device. both hands resting under the screen. The participant is asked, for each block of 20 seconds, to observe the visual feedback of the virtual right hand on the screen (flexion / extension movements of the fingers at 0.5 Hz).
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | 30 right handed healthy participants aged between 18 and 60. Receives: Device: Left virtual mirror therapy task; Device: Right virtual mirror therapy task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in the concentration of oxyhemoglobin during the task
Changes in the concentration of oxyhemoglobin during the task measured with fnirs device
Measured: Baseline
Mean change in the concentration of deoxyhemoglobin during the task
Changes in the concentration of deoxyhemoglobin during the task measured with fnirs device
Measured: Baseline
Secondary outcomes (2)
Compare the cortical regions involved during the different mirror therapy tasks
visual analog scale.
Measured: Baseline
Compare the feelings of the subjects
visual analog scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start9 Mar 2023
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BONNAL, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793762
- Sponsor's protocol ID
- CHRO-2022-17
- Acronym
- LARTHEMIRS
- Status last verified
- May 2023
- First submitted
- 8 Mar 2023
- Last updated
- 6 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartur G, Pratt H, Dickstein R, Frenkel-Toledo S, Geva A, Soroker N. Electrophysiological manifestations of mirror visual feedback during manual movement. Brain Res. 2015 May 5;1606:113-24. doi: 10.1016/j.brainres.2015.02.029. Epub 2015 Feb 23.
PubMed 25721791Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
PubMed 10376620Chang CS, Lo YY, Chen CL, Lee HM, Chiang WC, Li PC. Alternative Motor Task-Based Pattern Training With a Digital Mirror Therapy System Enhances Sensorimotor Signal Rhythms Post-stroke. Front Neurol. 2019 Nov 22;10:1227. doi: 10.3389/fneur.2019.01227. eCollection 2019.
PubMed 31824406Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
PubMed 22510258Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11. doi: 10.1016/j.neuroimage.2003.09.024.
PubMed 14597303Lee SH, Jin SH, An J. The difference in cortical activation pattern for complex motor skills: A functional near- infrared spectroscopy study. Sci Rep. 2019 Oct 1;9(1):14066. doi: 10.1038/s41598-019-50644-9.
PubMed 31575954Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
PubMed 21051765Ramachandran VS, Rogers-Ramachandran D, Cobb S. Touching the phantom limb. Nature. 1995 Oct 12;377(6549):489-90. doi: 10.1038/377489a0. No abstract available.
PubMed 7566144Thieme H, Morkisch N, Mehrholz J, Pohl M, Behrens J, Borgetto B, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2018 Jul 11;7(7):CD008449. doi: 10.1002/14651858.CD008449.pub3.
PubMed 29993119Wang J, Fritzsch C, Bernarding J, Krause T, Mauritz KH, Brunetti M, Dohle C. Cerebral activation evoked by the mirror illusion of the hand in stroke patients compared to normal subjects. NeuroRehabilitation. 2013;33(4):593-603. doi: 10.3233/NRE-130999.
PubMed 24018372
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Laterality on Cerebral Activation During a Virtual Mirror Therapy Task of Upper Limb Using fNIRS Technology in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05793762
- Acronym / sponsor ID
- LARTHEMIRS / CHRO-2022-17
- Conditions
- Healthy
- Keywords
- mirror therapy, laterality, cortical activation, functional near-infrared spectroscopy, upper limb
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 31 Mar 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 aim of this study is to investigate the differences in brain activation in healthy subjects during virtual mirror therapy tasks, depending on the laterality of the task. It seems that mirror therapy-related brain activation is greater when the visual feedback represents the non-dominant hand. The aim of this study is to highlight brain activation profiles during the use of virtual mirror therapy according to the lateralization of the feedback.
Detailed description
Stroke frequently leads to upper limb deficit. The recovery of motor skills depends on many factors including laterality. The literature shows that cerebral activation during motor tasks differs depending on whether one is right-handed or left-handed and whether one uses the dominant hand or not. These differences probably lead to different recovery mechanisms depending on the side of the lesion and the laterality. An imaging technique is particularly suitable for exploring these different mechanisms: 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 brain region increases its local blood flow. Oxygenated (HbO) and deoxygenated (HbR) hemoglobin absorb infrared light and it is then possible to identify the cerebral cortical regions involved in a given task. This technique therefore makes it possible to study cerebral activation under more ecological conditions than fMRI and is thus particularly suitable for exploring rehabilitation techniques.
This research aims to study and compare in healthy subjects, using an fNIRS apparatus, the brain regions involved in a virtual mirror therapy task according to the laterality of the task.
The investigations will be carried out by the principal investigator or by specialized technicians from the neurology functional exploration department.
The acquisition has a duration of 15 minutes, it begins with a rest period of 120 seconds, which corresponds to the baseline. two different tasks are performed during the acquisition for each subject:
- observation of visual feedback of the right hand (RVF)
- observation of visual feedback of the left hand (LVF)
The design is a block design, each task, which has a duration of 20 seconds, is carried out 10 times per acquisition. There is therefore a total of 20 tasks whose order will be randomized.
Before each acquisition, the movements of the right and left hands (finger flexion and extension) are recorded by a camera integrated in the virtual mirror therapy tool. Movements are performed at a frequency of 0.5 Hz which appears to be the optimal frequency for observing cortical activation using a metronome.
Between periods of movement, the subject is in a rest position for a period from 15 to 25 seconds.
The instructions given to each subject are to observe the visual feedback on the screen and not to perform any movement during the acquisition.
After recruiting the subjects, the study investigator will check the inclusion and exclusion criteria.
If the subject can integrate the protocol, the acquisition will then be planned.
On the day of the acquisition, the fNIRS acquisition helmet (Brite MKII) will be installed by a specialist technician and instructions will be given. The recording is then made.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Device: Left virtual mirror therapy task, Device: Right virtual mirror therapy task30 right handed healthy participants aged between 18 and 60. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- right handed healthy subjects aged between 18 and 60
Key inclusion criteria (3 listed)
- Age:18 to 60
- Right handed
- No neurological disease
Key exclusion criteria (2 listed)
- Person under tutorship or curatorship
- Known allergy to components of the fNIRS device: neoprene
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 |
|---|---|---|
| Left virtual mirror therapy taskthe participant is seated on a chair facing the screen of the virtual mirror therapy device. both hands resting under the screen. The participant is asked, for each block of 20 seconds, to observe the visual feedback of the virtual left hand on the screen (flexion / extension movements of the fingers at 0.5 Hz). | Device | Healthy participants |
| Right virtual mirror therapy taskthe participant is seated on a chair facing the screen of the virtual mirror therapy device. both hands resting under the screen. The participant is asked, for each block of 20 seconds, to observe the visual feedback of the virtual right hand on the screen (flexion / extension movements of the fingers at 0.5 Hz). | Device | Healthy participants |
Primary outcome
Mean change in the concentration of oxyhemoglobin during the task
Time frame: Baseline
Changes in the concentration of oxyhemoglobin during the task measured with fnirs device
Mean change in the concentration of deoxyhemoglobin during the task
Time frame: Baseline
Changes in the concentration of deoxyhemoglobin during the task measured with fnirs device
2 secondary outcomes
Compare the cortical regions involved during the different mirror therapy tasks
Time frame: Baseline
Compare the feelings of the subjects
Time frame: Baseline
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 6 May 2023.
- Background: PubMed 25721791Bartur G, Pratt H, Dickstein R, Frenkel-Toledo S, Geva A, Soroker N. Electrophysiological manifestations of mirror visual feedback during manual movement. Brain Res. 2015 May 5;1606:113-24. doi: 10.1016/j.brainres.2015.02.029. Epub 2015 Feb 23.
- Background: PubMed 10376620Altschuler EL, Wisdom SB, Stone L, Foster C, Galasko D, Llewellyn DM, Ramachandran VS. Rehabilitation of hemiparesis after stroke with a mirror. Lancet. 1999 Jun 12;353(9169):2035-6. doi: 10.1016/s0140-6736(99)00920-4. No abstract available.
- Background: PubMed 31824406Chang CS, Lo YY, Chen CL, Lee HM, Chiang WC, Li PC. Alternative Motor Task-Based Pattern Training With a Digital Mirror Therapy System Enhances Sensorimotor Signal Rhythms Post-stroke. Front Neurol. 2019 Nov 22;10:1227. doi: 10.3389/fneur.2019.01227. eCollection 2019.
- Background: PubMed 22510258Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
- Background: PubMed 14597303Giraux P, Sirigu A. Illusory movements of the paralyzed limb restore motor cortex activity. Neuroimage. 2003 Nov;20 Suppl 1:S107-11. doi: 10.1016/j.neuroimage.2003.09.024.
- Background: PubMed 31575954Lee SH, Jin SH, An J. The difference in cortical activation pattern for complex motor skills: A functional near- infrared spectroscopy study. Sci Rep. 2019 Oct 1;9(1):14066. doi: 10.1038/s41598-019-50644-9.
- Background: PubMed 21051765Michielsen ME, Selles RW, van der Geest JN, Eckhardt M, Yavuzer G, Stam HJ, Smits M, Ribbers GM, Bussmann JB. Motor recovery and cortical reorganization after mirror therapy in chronic stroke patients: a phase II randomized controlled trial. Neurorehabil Neural Repair. 2011 Mar-Apr;25(3):223-33. doi: 10.1177/1545968310385127. Epub 2010 Nov 4.
- Background: PubMed 7566144Ramachandran VS, Rogers-Ramachandran D, Cobb S. Touching the phantom limb. Nature. 1995 Oct 12;377(6549):489-90. doi: 10.1038/377489a0. No abstract available.
- Background: PubMed 29993119Thieme H, Morkisch N, Mehrholz J, Pohl M, Behrens J, Borgetto B, Dohle C. Mirror therapy for improving motor function after stroke. Cochrane Database Syst Rev. 2018 Jul 11;7(7):CD008449. doi: 10.1002/14651858.CD008449.pub3.
- Background: PubMed 24018372Wang J, Fritzsch C, Bernarding J, Krause T, Mauritz KH, Brunetti M, Dohle C. Cerebral activation evoked by the mirror illusion of the hand in stroke patients compared to normal subjects. NeuroRehabilitation. 2013;33(4):593-603. doi: 10.3233/NRE-130999.
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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.
Julien BONNAL principal investigator
CHR d'Orléans
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 3 inclusion and 2 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 6 May 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?
Mean change in the concentration of oxyhemoglobin during the task (time frame: Baseline). 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 NCT05793762, which also lists 10 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 6 May 2023.