StrokeVibraLCANCT05277519
Neuroplasticity After Proprioceptive Rehabiliation
An observational study of Stroke and Hemiparesis, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Hemiparesis, Traumatic Brain Injury
- What is being tested?
- Vibrations
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2022to 15 Dec 2027
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 56 patients randomly affected to the experimental group receiving active vibration or sham
Who may be able to join
- hemiparesis at least transient in lower limb following an acquired brain injury (stroke or traumatic brain injury)
- French spoken
- Affiliated to a French social insurance
- No previous traumatic, vascular or neurodegenerative injuries
- Having presented during the acute phase or presenting a motor deficit of one of the lower limbs
- Presenting an absence of autonomy of walking at the entrance of the rehabilitation department
- In the sub-acute phase, i.e. from 15 days to 6 months after the accident
- Presenting moderate cognitive disorders allowing them to understand instructions and give their consent
Who cannot join
- strong cognitive disorders
- maintenance of justice, tutelage, legal guardianship
- Pregnancy and breastfeeding
- Outpatients who do not have weekly follow-up in the rehabilitation department
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
Pitié-Salpêtrière Hospital
Paris, 75013
Eleonore Bayen, MD, PhD, eleonore.bayen@aphp.fr
Veronique Marchand-Pauvert, PhD, +33142161120, veronique.marchand-pauvert@inserm.fr
About this study
Official title: Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury
Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.
Read the detailed description
Randomized control trial : 28 patients with active vibrations vs. 28 patients with sham stimulation Subacute phase : D15 to 6 months after stroke or patients with traumatic brain injury with similar semiology as stroke (hemiparesis) Measure at baseline : Electrophysiological investigations (EMG,EEG, MRI, clinical evaluation) Treatment of 5 weeks with 3 sessions of vibrations or sham a week Evaluation at mid time (electrophysiology and clinical examinations) Final examination (electrophysiology, MRI and clinical examination)
- Conditions
- Stroke, Hemiparesis, Traumatic Brain Injury
- Being tested
- Vibrations
- Keywords
- Neuroplasticity, Electrophysiology, MRI, Neurophysiology, Muscle vibration
- Medical subject headings
- Stroke, Paresis, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrationsDevice
Sequenced muscle vibrations during 30 min., 3 times a week during 5 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline EMG
H-reflex and reciprocal inhibition
Measured: Evaluation at baseline (4 days before treatment)
Baseline EEG
SEP and resting state activity
Measured: Evaluation at baseline (4 days before treatment)
EMG change from baseline after 2-week treatment
H-reflex and reciprocal inhibition
Measured: Evaluation during the 3rd week of treatment
EEG change from baseline after 2-week treatment
SEP and resting state activity
Measured: Evaluation during the 3rd week of treatment
EMG change after the 5-week treatment
H-reflex and reciprocal inhibition
Measured: Evaluation 4 days after the end of the 5-week treatment
EEG change after the 5-week treatment
SEP and resting state activity
Measured: Evaluation 4 days after the end of the 5-week treatment
Secondary outcomes (19)
Baseline MD
Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI
Measured: Evaluation at baseline (4 days before treatment)
Baseline FA
Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI
Measured: Evaluation at baseline (4 days before treatment)
Baseline Muscle Strength
score to Medical Research Council scale
Measured: Evaluation at baseline (4 days before treatment)
Muscle Strength change from baseline after 2-week treatment
score to Medical Research Council scale
Measured: Evaluation during the 3rd week of treatment
Muscle Strength change from baseline after 5-week treatment
score to Medical Research Council scale
Measured: Evaluation 4 days after the end of the 5-week treatment
Baseline Spasticity
score to Modified Ashworth scale
Measured: Evaluation at baseline (4 days before treatment)
Spasticity change from baseline after 2-week treatment
score to Modified Ashworth scale
Measured: Evaluation during the 3rd week of treatment
Spasticity change from baseline after 5-week treatment
score to Modified Ashworth scale
Measured: Evaluation 4 days after the end of the 5-week treatment
Baseline sensorimotor function
subscore for lower limbs to Fugl meyer assessment
Measured: Evaluation at baseline (4 days before treatment)
Sensorimotor function change from baseline after 2-week treatment
subscore for lower limbs to Fugl meyer assessment
Measured: Evaluation during the 3rd week of treatment
Sensorimotor function change from baseline after 5-week treatment
subscore for lower limbs to Fugl meyer assessment
Measured: Evaluation 4 days after the end of the 5-week treatment
Baseline Balance
Score to Berg balance scale
Measured: Evaluation at baseline (4 days before treatment)
Balance change from baseline after 2-week treatment
Score to Berg balance scale
Measured: Evaluation during the 3rd week of treatment
Balance change from baseline after 5-week treatment
Score to Berg balance scale
Measured: Evaluation 4 days after the end of the 5-week treatment
Baseline walking
score to 10-m walking test
Measured: Evaluation at baseline (4 days before treatment)
Walking from baseline after 2-week treatment
score to 10-m walking test
Measured: Evaluation during the 3rd week of treatment
Walking from baseline after 5-week treatment
score to 10-m walking test
Measured: Evaluation 4 days after the end of the 5-week treatment
Change in MD
Evaluation of white matter integrity along the corticospinal tract by calculating the mean diffusivity (MD) evaluated from diffusion MRI
Measured: Evaluation 4 days after the end of the 5-week treatment
Change in FA
Evaluation of white matter integrity along the corticospinal tract by calculating the fraction of anisotropy (FA) evaluated from diffusion MRI
Measured: Evaluation 4 days after the end of the 5-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start16 Jun 2022
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Eleonore Bayen, MD, PhD, Principal investigator, Sorbonne University - AP-HP (Pitié-Salpêtrière Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05277519
- Sponsor's protocol ID
- C20-11
- Other IDs
- 2021-A00822-39
- Acronym
- VibraLCA
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2021
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05277519
- Acronym / sponsor ID
- VibraLCA / C20-11
- Conditions
- Stroke, Hemiparesis, Traumatic Brain Injury
- Keywords
- Neuroplasticity, Electrophysiology, MRI, Neurophysiology, Muscle vibration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 14 Mar 2022 (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.
Sequences of muscle tendon vibrations allow to reproduce the sensory feedback during movement like locomotion and kinaesthesia. It is known that such a treatment promotes motor recovery after stroke assuming that it enhances neuroplasticity. The aim of the research is to study the activity in cerebrospinal circuitry to evaluate the neuroplastic changes during and after instrumented proprioceptive rehabilitation relying on sequences of muscle vibration in subacute stroke stages.
Detailed description
Randomized control trial : 28 patients with active vibrations vs. 28 patients with sham stimulation Subacute phase : D15 to 6 months after stroke or patients with traumatic brain injury with similar semiology as stroke (hemiparesis) Measure at baseline : Electrophysiological investigations (EMG,EEG, MRI, clinical evaluation) Treatment of 5 weeks with 3 sessions of vibrations or sham a week Evaluation at mid time (electrophysiology and clinical examinations) Final examination (electrophysiology, MRI and clinical examination)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 56 patients randomly affected to the experimental group receiving active vibration or sham
Key inclusion criteria (8 listed)
- hemiparesis at least transient in lower limb following an acquired brain injury (stroke or traumatic brain injury)
- French spoken
- Affiliated to a French social insurance
- No previous traumatic, vascular or neurodegenerative injuries
- Having presented during the acute phase or presenting a motor deficit of one of the lower limbs
Key exclusion criteria (4 listed)
- strong cognitive disorders
- maintenance of justice, tutelage, legal guardianship
- Pregnancy and breastfeeding
- Outpatients who do not have weekly follow-up in the rehabilitation department
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 |
|---|---|---|
| VibrationsSequenced muscle vibrations during 30 min., 3 times a week during 5 weeks | Device | – |
Primary outcome
Baseline EMG
Time frame: Evaluation at baseline (4 days before treatment)
H-reflex and reciprocal inhibition
Baseline EEG
Time frame: Evaluation at baseline (4 days before treatment)
SEP and resting state activity
EMG change from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
H-reflex and reciprocal inhibition
EEG change from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
SEP and resting state activity
EMG change after the 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
H-reflex and reciprocal inhibition
EEG change after the 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
SEP and resting state activity
19 secondary outcomes
Baseline MD
Time frame: Evaluation at baseline (4 days before treatment)
Baseline FA
Time frame: Evaluation at baseline (4 days before treatment)
Baseline Muscle Strength
Time frame: Evaluation at baseline (4 days before treatment)
Muscle Strength change from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
Muscle Strength change from baseline after 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline Spasticity
Time frame: Evaluation at baseline (4 days before treatment)
Spasticity change from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
Spasticity change from baseline after 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline sensorimotor function
Time frame: Evaluation at baseline (4 days before treatment)
Sensorimotor function change from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
Sensorimotor function change from baseline after 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline Balance
Time frame: Evaluation at baseline (4 days before treatment)
Balance change from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
Balance change from baseline after 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
Baseline walking
Time frame: Evaluation at baseline (4 days before treatment)
Walking from baseline after 2-week treatment
Time frame: Evaluation during the 3rd week of treatment
Walking from baseline after 5-week treatment
Time frame: Evaluation 4 days after the end of the 5-week treatment
Change in MD
Time frame: Evaluation 4 days after the end of the 5-week treatment
Change in FA
Time frame: Evaluation 4 days after the end of the 5-week treatment
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 7 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
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Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
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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.
Eleonore Bayen, MD, PhD principal investigator
Sorbonne University - AP-HP (Pitié-Salpêtrière Hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiparesis, run by Institut National de la Santé Et de la Recherche Médicale, France 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 8 inclusion and 4 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 7 Jul 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. 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 Veronique Marchand-Pauvert, PhD (+33142161120, veronique.marchand-pauvert@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline EMG (time frame: Evaluation at baseline (4 days before treatment)). The study lists 6 primary outcomes in all. 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 7 Jul 2026; AzTrials last refreshed its copy on 5 Nov 2026.