NCT05743647

Brief 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). The investigators goal is to compare cerebral activation during the three different tasks using EEG and fNIRS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

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 15, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 20, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

February 15, 2023

Last Update Submit

July 31, 2023

Conditions

Healthy

Keywords

Virtual Mirror therapyElectroencephalographyNear infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

  • 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.

    Day 0

  • Change in the beta band after movement (Beta-Rebound).

    Beta Rebound power in dB normalized to a baseline before the movement.

    Day 0

Secondary Outcomes (2)

  • Mean change in the concentration of oxyhemoglobin during the task

    Day 0

  • Mean change in the concentration of deoxyhemoglobin during the task

    Day 0

Study Arms (2)

Young

40 right handed healthy subject aged between 18 and 40

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

Device: Observation (OBS)Device: Observation and imagination (OBS-IM)Device: Observation and realization (OBS-REAL)

Interventions

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.

OldYoung
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.

OldYoung
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

OldYoung

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Right handed healthy subjects aged between 18 and 75 years

You may qualify if:

  • 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)

You may not qualify if:

  • Minor subjects
  • Adults under guardianship
  • Adults under guardianship
  • Pregnant or breastfeeding women
  • Subjects who have objected to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France

Location

Related Publications (7)

  • 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.

    PMID: 30194016BACKGROUND

  • Bonnal 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.

    PMID: 35898041BACKGROUND

  • Borges 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.

    PMID: 30380586BACKGROUND

  • Coll 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.

    PMID: 28559380BACKGROUND

  • Fox 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.

    PMID: 26689088BACKGROUND

  • Macuga 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.

    PMID: 22005592BACKGROUND

  • Adham 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.

    PMID: 38978051DERIVED

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Pascal GIRAUX, Pr

    CHU de Saint Etienne - Hôpital Bellevue

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

February 20, 2023

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Locations

FR(1)