Muscle Vibration as a Countermeasure Against Hypoactivity-induced (NEUROVIB-ULLS)

May 22, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

Effects of Focal Muscle Vibration as a Countermeasure Against Hypoactivity-induced Neuromuscular Deconditioning

Muscle deconditioning, characterized by a loss of muscle mass and strength, is a frequent consequence of prolonged lower limb unloading. Beyond muscle mass loss, reduced neural drive contributes significantly to strength decline, highlighting the need for interventions targeting neuromuscular function during immobilization. Focal muscle vibration (FMV) has shown promise in modulating neuromuscular excitability by activating muscle spindle afferents and inducing cortical adaptations. Chronic use of FMV has been associated with significant strength gains and improved neural command. This makes FMV an effective rehabilitation tool. Its simplicity and non-invasiveness further make it a practical countermeasure.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study hypothesizes that a 10-day FMV protocol can induce neural adaptations to limit strength loss during unilateral lower limb suspension, offering a novel strategy against neuromuscular function decline.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Men and women.
  • Aged 18 to 45 years.
  • Body Mass Index (BMI) between 18,5 and 24,9 kg/m².
  • Engaging in at least 1.5 hours per week of physical activity (e.g., brisk walking, running, swimming, cycling).
  • Provided informed consent after receiving detailed information about the study.
  • Affiliated with or beneficiaries of a social security system

Exclusion Criteria:

  • Chronic cardiovascular, neuromuscular, bone, metabolic, and/or inflammatory disorders.
  • Personal history and/or risk factors for thrombosis.
  • Use of antidepressant medications.
  • Use of neuroactive substances likely to alter corticospinal excitability (e.g., hypnotics, antiepileptics, psychotropics, muscle relaxants) during the study.
  • Recent bone or ligament trauma within the past 12 months.
  • Inability to perform the physical efforts required for the study.
  • Recent participation in a sporting competition or intense, unusual physical activity within the past month.
  • Corticosteroid treatment within the past 3 months.
  • Any skin lesions at the planned vibrator application site.
  • Simultaneous participation in another interventional medical study.
  • Pregnant or breastfeeding women.
  • Individuals unable to understand the purpose and conditions of the study or unable to provide informed consent.
  • Individuals deprived of liberty or under guardianship

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: VIBRATION
Participants will benefit a local vibration countermeasure program for the knee extensor muscles.
Device: Focal muscle vibration
focal muscle vibration sessions, using small and portable vibrator devices.
Sham Comparator: CONTROLE
the control group WILL not receive this countermeasure.
Device: NO Focal muscle vibration
The control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Isometric force measurement
Time Frame: Day 1, 7, 14, 28, 33
Maximal isometric force (% decrease) in knee extension of the immobilized leg will be evaluated
Day 1, 7, 14, 28, 33

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum voluntary force measurement
Time Frame: Day 1, 7, 14, 28, 33
Maximum voluntary force (Nm) in knee extension, assessed in isometric (for the immobilized leg and also for the contralateral leg), concentric (+60°/s and +180°/s) and eccentric (-60°/s) conditions.
Day 1, 7, 14, 28, 33
Jumping performance measurement
Time Frame: Day 1, 7, 14, 28, 33
Jumping performance (height, in cm), assessed in vertical jump tests (Squat Jump and Counter Movement Jump).
Day 1, 7, 14, 28, 33
Postural balance measurement
Time Frame: Day 1, 7, 14, 28, 33
Postural balance performance (displacement of center of pressure, in mm), assessed in a unipodal postural balance test performed on a strength platform
Day 1, 7, 14, 28, 33
Neuromuscular fatigue measurement
Time Frame: Day 1, 7, 14, 28, 33
Neuromuscular fatigue (decrease in maximum voluntary force (in %), assessed during a fatigue protocol consisting of quadriceps muscle contractions at incremental force levels.
Day 1, 7, 14, 28, 33
Force-velocity-endurance measurement
Time Frame: Day 1, 7, 14, 28, 33
Force-velocity-endurance profile, assessed during an effort performed on a cycloergometer at linearly decreasing power values.
Day 1, 7, 14, 28, 33
Voluntary activation level evaluation
Time Frame: Day 1, 7, 14, 28, 33
Voluntary activation level (in %), determined by the force increment obtained following stimulation during a maximal voluntary isometric contraction.
Day 1, 7, 14, 28, 33
Cortico-spinal excitability measurement
Time Frame: Day 1, 7, 14, 28, 33
Cortico-spinal excitability, assessed by electromyographic responses (motor evoked potentials, in mV) evoked by transcranial magnetic stimulation (TMS).
Day 1, 7, 14, 28, 33
Spinal excitability evaluation
Time Frame: Day 1, 7,14 , 28, 33
Spinal excitability (i.e. spinal reflexes, in mV), assessed by recording EMG responses evoked by electrical stimulation of the lumbar vertebrae.
Day 1, 7,14 , 28, 33
Cortical activation of sensorimotor areas measurement
Time Frame: Day 1, 7, 14, 28, 33
Cortical activation of sensorimotor areas, assessed by recording the electroencephalographic (EEG) signal during submaximal isometric contractions.
Day 1, 7, 14, 28, 33
Muscle volume measurement
Time Frame: Day 1, 7, 14, 28, 33
Muscle volume will be assessed by ultrasound of the thigh muscles (in cm2).
Day 1, 7, 14, 28, 33
Determination of plasma molecular markers of bone and muscle remodeling
Time Frame: Day 1, 7, 14, 28, 33
Assessment of blood factors of nerve (BDNF) and muscle remodeling (circulating steroids, insulin, GH, IGF-1, myostatin, activinA, follistatin).
Day 1, 7, 14, 28, 33
Determination of plasma molecular markers of bone and muscle remodeling
Time Frame: Day 1, 7, 14, 28, 33
Evaluation of bone remodeling factors by bAP, CTx, P1NP and Trap5b assays
Day 1, 7, 14, 28, 33
Plasma molecular markers of thrombotic risk evaluation
Time Frame: Day 1, 7, 14, 28, 33
Plasma molecular markers of thrombotic risk will be assessed by blood sampling followed by assay of HSP47 and D-dimer factors.
Day 1, 7, 14, 28, 33

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LEONARD FEASSON, PHD, CENTRE HOSPITALIER UNIVERSITAIRE SAINT-ETIENNE

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24CH295
  • 2024-A02769-38 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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