NCT06845176

Brief Summary

Kinesthetic motor imagery (kMI) involves imagining the sensations of movement, activating brain regions similar to actual movement execution. It is widely used to maintain or restore motor functions, particularly in rehabilitation. Tendon vibration (TV), which stimulates proprioceptive receptors can also enhance corticospinal excitability and promote neuroplasticity. This project investigates the coupling of kMI and TV through three modalities: simultaneous application, TV application between kMI trials, or pre-application of TV to precondition the nervous system before kMI trials. The effectiveness and quality of kMI will be assessed by corticospinal excitability measurements using transcranial magnetic stimulation and EEG measures. Conducting this study in healthy participants will inform the development of optimized clinical interventions for immobilized or mobility-reduced patients.

Trial Health

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Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

February 20, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

Kinesthetic motor imageryTendon vibrationCorticospinal excitabilityNeuroplasticityElectroencephalography

Outcome Measures

Primary Outcomes (1)

  • Optimization of kMI

    We will measure corticospinal excitability. This will be assessed by the area (in mV.%) under the curve representing the amplitude of motor-evoked potentials (MEPs, in mV) recorded via electromyography, as a function of transcranial magnetic stimulation intensity (in % of the stimulator's maximal output) required to evoke these potentials.

    30 minutes

Study Arms (3)

Simultaneous application of TV and kMI

EXPERIMENTAL

Simultaneous application of Tendon Vibration and Kinesthesic Motor Imagery

Device: Tendon vibration (TV)Other: Kinesthetic motor imagery (kMI)

TV application between kMI trials

EXPERIMENTAL

Tendon Vibration application between Kinesthesic Motor Imagery

Device: Tendon vibration (TV)Other: Kinesthetic motor imagery (kMI)

TV as a pre-conditionning for kMI

EXPERIMENTAL

Tendon Vibration application as a pre-conditionning for Kinesthesic Motor Imagery

Device: Tendon vibration (TV)Other: Kinesthetic motor imagery (kMI)

Interventions

We use the VIBRAMOOV PHYSIO device which delivers local muscle vibrations at frequencies of 80 Hz and an amplitude of 1 mm.

Simultaneous application of TV and kMITV application between kMI trialsTV as a pre-conditionning for kMI

kMI is a mental technique in which an individual visualizes performing a movement without physically executing it. This process involves the internal representation of the sensations associated with the movement, engaging neural pathways similar to those activated during actual physical movement. kMI stimulates key motor and sensory areas in the brain, promoting neuroplasticity and enhancing motor performance.

Simultaneous application of TV and kMITV application between kMI trialsTV as a pre-conditionning for kMI

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women aged 18 to 50 years.
  • Affiliated with or beneficiaries of a social security system.
  • Provided written informed consent freely after being informed of the study's purpose, procedures, and potential risks.

You may not qualify if:

  • History of pathology or surgery affecting upper limb motor function within 6 months prior to the study.
  • Chronic neurological, motor, or psychiatric disorders.
  • Use of neuroactive substances likely to alter corticospinal excitability (e.g., hypnotics, antiepileptics, psychotropics, muscle relaxants) during the study period.
  • Contraindications to transcranial magnetic stimulation
  • Simultaneous participation in another interventional study or participation in such a study within 30 days prior to this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRMIS-Hôpital Nord

Saint-Etienne, France, 42055, France

Location

Study Officials

  • Léonard FEASSON, PhD

    Centre Hospitalier Universiatire de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana RIMAUD, Doctor of Science

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

March 11, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

This study is being conducted in a single department of the ST-ETIENNE University Hospital.

Locations