Study of Cerebral Activation by fNIRS During Vibration-induced Illusion of Movement in Healthy and Stroke Participants. (VIBRANIRS)

July 7, 2025 updated by: Centre Hospitalier Régional d'Orléans

Vibration-induced Movement Illusion Causes Cerebral Haemodynamic Changes: A fNIRS Study.

The purpose of this study is to investigate the cerebral activation of healthy and stroke participants in 4 or 2 different conditions (repeated 2 times) of vibration-induced illusion of movement respectively, resulting in 8 or 4 vibration blocks with 3 vibrations per block. The frequency of the vibration being 80 Hz.

Healthy participants:

  • Right arm, eyes opened
  • Right arm, eyes closed
  • Left arm, eyes opened
  • Left arm, eyes closed

Stroke participants:

  • Deficient side, eyes opened
  • Deficient side, eyes closed

The aim is to compare the subjective sensation of movement score and cerebral activations of healthy/stroke participants depending on the condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Perceived sensations of limb and movements (kinesthesia) allow us to situate ourselves without visual feedback and not dedicate all of our attention to everyday tasks such as walking or taking and holding an object. These perceived conscious sensations come from receptors called proprioceptors which are located in the skin, joints and muscles. When a limb is moving and a muscle is stretched, the main sensation of limb stretching comes from the stimulation of a proprioceptor called the muscle spindle, more specifically from its primary ending called the 1a fibber. Artificially, 1a fibbers can be (optimally) stimulated by vibration of the muscle around 80 Hz. When stimulating 1a fibbers of the triceps, a signal of stretching is produced and an illusion of flexion can be felt as long as their no other contrary feedback involved such as vibration of the antagonist muscle or visual feedback of the immobile limb as it provides a more reliable information to the brain. As of now, neural correlates to muscle spindle vibration and illusion of movement have not been fully characterize in healthy participants and are not known in stroke participants.

To investigate the effect of vibration-induced illusion of movement on cerebral activations in healthy and stroke participants, the investigators propose to use an innovative tool of neuroimaging, the functional near infrared spectroscopy (fNIRS).

fNIRS allows to investigate cortical cerebral activations by measuring cerebral haemodynamic variations. Indeed, just like fMRI, it relies on the haemodynamic response function (HRF) caused by neurovascular coupling. Its portability and non-invasiveness make it a great tool to study brain activations in a more ecological environment (in a standing or sitting position for example).

This research aims to study and compare the subjective sensation of movement and the cortical cerebral areas involved in muscle spindle vibration and illusion of movement in healthy and stroke participants.

The protocol consists of 4 or 2 different conditions (repeated 2 times) of vibration-induced illusion of movement in healthy and stroke participants respectively, resulting in 8 or 4 vibration blocks with 3 vibrations per block:

Healthy participants, 2 times each (24 vibrations):

  • Right arm, eyes opened (no-illusion condition; RO)
  • Right arm, eyes closed (illusion condition; RC)
  • Left arm, eyes opened (no-illusion condition; LO)
  • Left arm, eyes closed (illusion condition; LC)

Stroke participants, 2 times each (12 vibrations):

  • Deficient side, eyes opened (no-illusion condition; DO)
  • Deficient side, eyes closed (illusion condition; DC)

Conditions order is pseudorandomized, participants can start by the left or the right arm with eyes opened or closed. When starting with either the left or right arm, all conditions are completed before moving on to the other arm (for healthy participants). In total, the number of participants starting with right or left vibration should be the same.

The fNIRS devices that will be used are the Brite MKII and Brite MKIII (Artinis Medical system, Netherlands).

The vibration tool that will be used is a vibrator from VibraMoov. The subjective sensation of movement will be analyzed using the Standardized Kinesthetic Illusion Procedure (SKIP) scale. Participants will have to report their sensation of movement after each condition (3 vibrations block) from 0 to 3, 0 being no sensation of movement and 3 being a clear and precise sensation of movement. Participants will also have to describe the direction of movement, a score of 1 will be attributed if the movement described correspond to the one expected and a score of 0 will be attributed for every other movements.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orleans, France, 45067
        • CHU d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-85 years old
  • Able to sign a consent form
  • Sufficient command of the French language to understand instructions
  • Affiliated to a social security scheme

Healthy participants:

  • Right handed
  • No neurological disease or motor deficit

Stroke participants:

  • Stroke volunteers in acute phase (before day 14 post-stroke)
  • Not aphasic
  • Able to maintain sitting position without difficulty
  • Deficit moteur
  • Able to sign a consent form

Exclusion Criteria:

  • Person under tutorship or curatorship
  • Known allergy to of the fNIRS cap components: neoprene
  • No vibrations feeling on the deficient side
  • Vigilance-modifying drugs (high-dose psychotropics, antispastic drugs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vibration-induced illusion of movement

The protocol consists of 4 or 2 different conditions (repeated 2 times) of vibration-induced illusion of movement in healthy and stroke participants respectively, resulting in 8 or 4 vibration blocks with 3 vibrations per block:

Healthy participants, 2 times each (24 vibrations):

  • Right arm, eyes opened (no-illusion condition; RO)
  • Right arm, eyes closed (illusion condition; RC)
  • Left arm, eyes opened (no-illusion condition; LO)
  • Left arm, eyes closed (illusion condition; LC)

Stroke participants, 2 times each (12 vibrations):

  • Deficient side, eyes opened (no-illusion condition; DO)
  • Deficient side, eyes closed (illusion condition; DC)
Other: vibration-induced illusion of movement
Conditions order is pseudorandomized, participants can start by the left or the right arm with eyes opened or closed. When starting with either the left or right arm, all conditions are completed before moving on to the other arm (for healthy participants). In total, the number of participants starting with right or left vibration should be the same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in the concentration of oxyhemoglobin during the task
Time Frame: Day 0
The HbO2 signals are considered as indicators of the hemodynamic response.
Day 0
Mean change in the concentration of deoxyhemoglobin during the task
Time Frame: Day 0
The HbR signals are considered as indicators of the hemodynamic response.
Day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SKIP scale
Time Frame: Day 0
The subjective sensation of movement will be analyzed using the Standardized Kinesthetic Illusion Procedure (SKIP) scale. Participants will have to report their sensation of movement after each condition (3 vibrations block) from 0 to 3, 0 being no sensation of movement and 3 being a clear and precise sensation of movement. Participants will also have to describe the direction of movement, a score of 1 will be attributed if the movement described correspond to the one expected and a score of 0 will be attributed for every other movements.
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Canan OZSANCAK, Dr, CHU d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

June 25, 2025

Study Completion (Actual)

June 25, 2025

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 7, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2023-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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