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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05793762
Other study ID # CHRO-2022-17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2023
Est. completion date March 23, 2023

Study information

Verified date May 2023
Source Centre Hospitalier Régional d'Orléans
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 23, 2023
Est. primary completion date March 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Age:18 to 60 - Right handed - No neurological disease Exclusion Criteria: - Person under tutorship or curatorship - Known allergy to components of the fNIRS device: neoprene

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Left virtual mirror therapy task
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 task
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).

Locations

Country Name City State
France CHR Orléans Orléans

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (10)

Altschuler 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. — View Citation

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. — View Citation

Chang 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. — View Citation

Ferrari 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. — View Citation

Giraux 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. — View Citation

Lee 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. — View Citation

Michielsen 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. — View Citation

Ramachandran 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. — View Citation

Thieme 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. — View Citation

Wang 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change in the concentration of oxyhemoglobin during the task Changes in the concentration of oxyhemoglobin during the task measured with fnirs device Baseline
Primary Mean change in the concentration of deoxyhemoglobin during the task Changes in the concentration of deoxyhemoglobin during the task measured with fnirs device Baseline
Secondary Compare the cortical regions involved during the different mirror therapy tasks visual analog scale. Baseline
Secondary Compare the feelings of the subjects visual analog scale. Baseline
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