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

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: Recruiting
• Conditions: Healthy Volunteer Study; Vibration Therapy; Hypoactivity
• Intervention / Treatment: Device: Focal muscle vibration; Device: NO Focal muscle vibration

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: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LEONARD FEASSON, PHD; Phone Number: +33 (0)477120383; Email: leonard.feasson@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Recruiting
    • Centre Hospitalier Universitaire
    • Contact: LEONARD FEASSON, PHD; Phone Number: +33 (0)477120383; Email: leonard.feasson@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Isometric force measurement	Maximal isometric force (% decrease) in knee extension of the immobilized leg will be evaluated	Day 1, 7, 14, 28, 33

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum voluntary force measurement	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: LEONARD FEASSON, PHD, CENTRE HOSPITALIER UNIVERSITAIRE SAINT-ETIENNE

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: June 12, 2025
• First Posted (Actual): June 13, 2025

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Vibration; hypoactivity; neuromuscular deconditionning
• Additional Relevant MeSH Terms: Behavior; Sedentary Behavior
• Other Study ID 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