NCT04738851

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable healthy

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

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

24 days

First QC Date

February 1, 2021

Last Update Submit

May 11, 2021

Conditions

Keywords

mirror therapynear infrared spectroscopycerebral activation

Outcome Measures

Primary Outcomes (1)

  • Compare the level of precuneus activation during conventional mirror therapy (TMC) and virtual mirror therapy (TMV)

    Changes in the concentration of oxyhemoglobin and deoxyhemoglobin measured with fnirs device

    Day 0

Secondary Outcomes (8)

  • Compare the level of activation of the precuneus during TMC and TC.

    Day 0

  • Compare the level of precuneus activation during TMV and TC.

    Day 0

  • Compare the level of activation of contralateral motor regions to visual feedback during TMC and TMV.

    Day 0

  • Compare the level of activation of the contralateral motor regions to visual feedback during TMV and TC.

    Day 0

  • Compare the level of activation of the contralateral motor regions to visual feedback during TMC and TC.

    Day 0

  • +3 more secondary outcomes

Study Arms (1)

healthy volunteers

EXPERIMENTAL

Virtual mirror therapy task : TMV Classic mirror therapy task : TMC Control task :TC

Other: Therapy Mirror task

Interventions

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.

healthy volunteers

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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 (16)

  • 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
  • Bae SJ, Jang SH, Seo JP, Chang PH. The Optimal Speed for Cortical Activation of Passive Wrist Movements Performed by a Rehabilitation Robot: A Functional NIRS Study. Front Hum Neurosci. 2017 Apr 20;11:194. doi: 10.3389/fnhum.2017.00194. eCollection 2017.

    PMID: 28473763BACKGROUND
  • Bai Z, Fong KNK, Zhang J, Hu Z. Cortical mapping of mirror visual feedback training for unilateral upper extremity: A functional near-infrared spectroscopy study. Brain Behav. 2020 Jan;10(1):e01489. doi: 10.1002/brb3.1489. Epub 2019 Dec 5.

    PMID: 31805613BACKGROUND
  • Brunetti M, Morkisch N, Fritzsch C, Mehnert J, Steinbrink J, Niedeggen M, Dohle C. Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study. Restor Neurol Neurosci. 2015;33(4):421-34. doi: 10.3233/RNN-140421.

    PMID: 26409402BACKGROUND
  • Calautti C, Jones PS, Naccarato M, Sharma N, Day DJ, Bullmore ET, Warburton EA, Baron JC. The relationship between motor deficit and primary motor cortex hemispheric activation balance after stroke: longitudinal fMRI study. J Neurol Neurosurg Psychiatry. 2010 Jul;81(7):788-92. doi: 10.1136/jnnp.2009.190512. Epub 2010 Apr 14.

    PMID: 20392975BACKGROUND
  • 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
  • Darbois N, Guillaud A, Pinsault N. Do Robotics and Virtual Reality Add Real Progress to Mirror Therapy Rehabilitation? A Scoping Review. Rehabil Res Pract. 2018 Aug 19;2018:6412318. doi: 10.1155/2018/6412318. eCollection 2018.

    PMID: 30210873BACKGROUND
  • 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
  • Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.

    PMID: 25416737BACKGROUND
  • Inagaki Y, Seki K, Makino H, Matsuo Y, Miyamoto T, Ikoma K. Exploring Hemodynamic Responses Using Mirror Visual Feedback With Electromyogram-Triggered Stimulation and Functional Near-Infrared Spectroscopy. Front Hum Neurosci. 2019 Feb 26;13:60. doi: 10.3389/fnhum.2019.00060. eCollection 2019.

    PMID: 30863295BACKGROUND
  • Jihun Kim, Jaehyo Kim. Robot-assisted mirroring exercise as a physical therapy for hemiparesis rehabilitation. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:4243-4246. doi: 10.1109/EMBC.2017.8037793.

    PMID: 29060834BACKGROUND
  • Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7.

    PMID: 12907818BACKGROUND
  • Lee HM, Li PC, Fan SC. Delayed mirror visual feedback presented using a novel mirror therapy system enhances cortical activation in healthy adults. J Neuroeng Rehabil. 2015 Jul 11;12:56. doi: 10.1186/s12984-015-0053-1.

    PMID: 26160599BACKGROUND
  • Li YC, Wu CY, Hsieh YW, Lin KC, Yao G, Chen CL, Lee YY. The Priming Effects of Mirror Visual Feedback on Bilateral Task Practice: A Randomized Controlled Study. Occup Ther Int. 2019 Nov 26;2019:3180306. doi: 10.1155/2019/3180306. eCollection 2019.

    PMID: 31824233BACKGROUND
  • Bonnal J, Ozsancak C, Prieur F, Auzou P. Video mirror feedback induces more extensive brain activation compared to the mirror box: an fNIRS study in healthy adults. J Neuroeng Rehabil. 2024 May 14;21(1):78. doi: 10.1186/s12984-024-01374-1.

Study Officials

  • Julien BONNAL

    CHR d'Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 4, 2021

Study Start

February 8, 2021

Primary Completion

March 4, 2021

Study Completion

March 4, 2021

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations