NCT05793762

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

March 9, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

14 days

First QC Date

March 8, 2023

Last Update Submit

May 5, 2023

Conditions

Keywords

mirror therapylateralitycortical activationfunctional near-infrared spectroscopyupper limb

Outcome Measures

Primary 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

    Baseline

  • 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 Outcomes (2)

  • Compare the cortical regions involved during the different mirror therapy tasks

    Baseline

  • Compare the feelings of the subjects

    Baseline

Study Arms (1)

Healthy participants

30 right handed healthy participants aged between 18 and 60.

Device: Left virtual mirror therapy taskDevice: Right virtual mirror therapy task

Interventions

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).

Healthy participants

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).

Healthy participants

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

right handed healthy subjects aged between 18 and 60

You may qualify if:

  • Age:18 to 60
  • Right handed
  • No neurological disease

You may not qualify if:

  • Person under tutorship or curatorship
  • Known allergy to components of the fNIRS device: neoprene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Orléans

Orléans, 45067, France

Location

Related Publications (10)

  • 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.

    PMID: 25721791BACKGROUND
  • 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.

    PMID: 10376620BACKGROUND
  • 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.

    PMID: 31824406BACKGROUND
  • 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.

    PMID: 22510258BACKGROUND
  • 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.

    PMID: 14597303BACKGROUND
  • 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.

    PMID: 31575954BACKGROUND
  • 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.

    PMID: 21051765BACKGROUND
  • 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.

    PMID: 7566144BACKGROUND
  • 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.

    PMID: 29993119BACKGROUND
  • 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.

    PMID: 24018372BACKGROUND

Study Officials

  • Julien BONNAL

    CHR d'Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 31, 2023

Study Start

March 9, 2023

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Locations