Vibration TherapyNEUROVIB-ULLSNCT07021079
Muscle Vibration as a Countermeasure Against Hypoactivity-induced
A study testing Focal muscle vibration and NO Focal muscle vibration in people with Vibration Therapy and Healthy Volunteer Study, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vibration Therapy, Healthy Volunteer Study, Hypoactivity
- What is being tested?
- Focal muscle vibration and NO Focal muscle vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire
Saint-Etienne, 42055
LEONARD FEASSON, PHD, (0)477120383 ext. +33, leonard.feasson@chu-st-etienne.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Vibration Therapy, Healthy Volunteer Study, Hypoactivity
- Being tested
- Focal muscle vibration, NO Focal muscle vibration
- Keywords
- hypoactivity, neuromuscular deconditionning, Vibration
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focal muscle vibrationDevice
focal muscle vibration sessions, using small and portable vibrator devices.
NO Focal muscle vibrationDevice
The control group will not receive any intervention.
| Study group | Role | What they receive |
|---|---|---|
| VIBRATION | Active comparator | Participants will benefit a local vibration countermeasure program for the knee extensor muscles. Receives: Device: Focal muscle vibration |
| CONTROLE | Sham comparator | the control group WILL not receive this countermeasure. Receives: Device: NO Focal muscle vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric force measurement
Maximal isometric force (% decrease) in knee extension of the immobilized leg will be evaluated
Measured: Day 1, 7, 14, 28, 33
Secondary outcomes (13)
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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 1, 7, 14, 28, 33
Muscle volume measurement
Muscle volume will be assessed by ultrasound of the thigh muscles (in cm2).
Measured: 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).
Measured: 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
Measured: 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.
Measured: Day 1, 7, 14, 28, 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start16 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vibration TherapyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEONARD FEASSON, PHD, Principal investigator, CENTRE HOSPITALIER UNIVERSITAIRE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021079
- Sponsor's protocol ID
- 24CH295
- Other IDs
- 2024-A02769-38
- Acronym
- NEUROVIB-ULLS
- Status last verified
- May 2026
- First submitted
- 10 Mar 2025
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Focal Muscle Vibration as a Countermeasure Against Hypoactivity-induced Neuromuscular Deconditioning
- ClinicalTrials.gov ID
- NCT07021079
- Acronym / sponsor ID
- NEUROVIB-ULLS / 24CH295
- Conditions
- Vibration Therapy, Healthy Volunteer Study, Hypoactivity
- Keywords
- hypoactivity, neuromuscular deconditionning, Vibration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIBRATION | Active comparator | Device: Focal muscle vibrationParticipants will benefit a local vibration countermeasure program for the knee extensor muscles. |
| CONTROLE | Sham comparator | Device: NO Focal muscle vibrationthe control group WILL not receive this countermeasure. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focal muscle vibrationfocal muscle vibration sessions, using small and portable vibrator devices. | Device | VIBRATION |
| NO Focal muscle vibrationThe control group will not receive any intervention. | Device | CONTROLE |
Primary outcome
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
13 secondary outcomes
Maximum voluntary force measurement
Time frame: Day 1, 7, 14, 28, 33
Jumping performance measurement
Time frame: Day 1, 7, 14, 28, 33
Postural balance measurement
Time frame: Day 1, 7, 14, 28, 33
Neuromuscular fatigue measurement
Time frame: Day 1, 7, 14, 28, 33
Force-velocity-endurance measurement
Time frame: Day 1, 7, 14, 28, 33
Voluntary activation level evaluation
Time frame: Day 1, 7, 14, 28, 33
Cortico-spinal excitability measurement
Time frame: Day 1, 7, 14, 28, 33
Spinal excitability evaluation
Time frame: Day 1, 7,14 , 28, 33
Cortical activation of sensorimotor areas measurement
Time frame: Day 1, 7, 14, 28, 33
Muscle volume measurement
Time frame: Day 1, 7, 14, 28, 33
Determination of plasma molecular markers of bone and muscle remodeling
Time frame: Day 1, 7, 14, 28, 33
Determination of plasma molecular markers of bone and muscle remodeling
Time frame: Day 1, 7, 14, 28, 33
Plasma molecular markers of thrombotic risk evaluation
Time frame: Day 1, 7, 14, 28, 33
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LEONARD FEASSON, PHD principal investigator
CENTRE HOSPITALIER UNIVERSITAIRE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focal muscle vibration and NO Focal muscle vibration in people with Vibration Therapy and Healthy Volunteer Study, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LEONARD FEASSON, PHD ((0)477120383 ext. +33, leonard.feasson@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric force measurement (time frame: Day 1, 7, 14, 28, 33). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.