Exploring neuroplasticity through proprioceptive rehabilitation with muscle vibrations
Neuroplasticity Induced by Functional Muscle Tendon Vibrations in Patients With Acquired Brain Injury
Institut National de la Santé Et de la Recherche Médicale, France · NCT05277519
This study is testing if using muscle vibrations can help improve brain recovery and movement in people who are healing from a stroke or brain injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France (other gov) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05277519 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of muscle tendon vibrations on neuroplasticity in patients recovering from stroke or traumatic brain injury. It involves a randomized control design with 28 patients receiving active vibrations and 28 receiving sham stimulation over a 5-week treatment period. Participants will undergo various electrophysiological assessments, including EMG, EEG, and MRI, to evaluate changes in cerebrospinal circuitry and motor recovery. The study aims to enhance understanding of how proprioceptive rehabilitation can promote neuroplastic changes during the subacute phase of recovery.
Who should consider this trial
Good fit: Ideal candidates are individuals with transient hemiparesis in the lower limb due to stroke or traumatic brain injury, who are in the subacute phase of recovery.
Not a fit: Patients with severe cognitive disorders or those unable to understand instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor recovery outcomes for patients with hemiparesis following stroke or traumatic brain injury.
How similar studies have performed: While the specific approach of using muscle vibrations for neuroplasticity is novel, similar studies have shown promise in enhancing motor recovery through proprioceptive feedback.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * strong cognitive disorders * maintenance of justice, tutelage, legal guardianship * Pregnancy and breastfeeding * Outpatients who do not have weekly follow-up in the rehabilitation department
Where this trial is running
Paris
- Pitié-Salpêtrière Hospital — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Eleonore Bayen, MD, PhD — Sorbonne University - AP-HP (Pitié-Salpêtrière Hospital)
- Study coordinator: Veronique Marchand-Pauvert, PhD
- Email: veronique.marchand-pauvert@inserm.fr
- Phone: +33142161120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Hemiparesis, Traumatic Brain Injury, Neuroplasticity, Electrophysiology, MRI, Neurophysiology, Muscle vibration