NCT05547152 Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis
| NCT ID | NCT05547152 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Peripheral Facial Palsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-02 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-08-02 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Peripheral facial palsy affects 15 to 40 people per 100,000 inhabitants and induces important functional and social repercussions. Synkinesis is a frequent after-effect of facial palsy recovery, consisting of involuntary facial spasms that disturb the gestural harmony and can go as far as a painful hypertonic spasm. More than 55% of patients recovering from facial palsy will develop transient or permanent synkinesis. These facial hypertonias have two main causes: imperfect axonal regeneration, which is all the more important as the damage is proximal, and hyperexcitability of the facial nerve nucleus due to a lack of central control. Management is therefore essential for the functional restoration of the face, especially since synkinesis do not evolve spontaneously. The main treatments are currently botulinum toxin injection, acting on the motor plate, and functional rehabilitation, consisting on local muscle relaxation and central motor control work. In recent years, therapies based on biofeedback and acting on central motor control have shown interesting results, and technological advances in virtual reality have made it possible to deepen this treatment in patients suffering from stroke, limb trauma or Parkinson's disease. In this project, the investigators evaluate the contribution of virtual reality to the management of facial palsy, and hypothesize that self-rehabilitation using this technology will improve motor control of the skin muscles and reduce complications related to their hypertonia such as synkinesis.
Eligibility Criteria
Inclusion Criteria: * Patient with recent onset peripheral facial palsy (≤ 12 months). * Patient with peripheral facial palsy of grade ≥ III on the House \& Brackmann score * Patient of legal age (≥ 18 years) * Patient with appropriate information and informed consent Exclusion Criteria: * Patient with central facial palsy * Patient with peripheral facial palsy of \> 12 months onset * Patient with peripheral facial palsy of grade \< III House \& Brackmann score * Patient who has previously undergone palliative surgery * Patient undergoing a botulinum toxin injection protocol * Patients benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, pregnant or breast-feeding women and patients in emergency situations * Patients who have not provided informed consent * Patients with cognitive disorders that do not allow them to follow the proposed self-education protocol * Blind or visually impaired patients (visual acuity of the better eye after correction ≤ 4/10)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05547152 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Peripheral Facial Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05547152 currently recruiting?
Yes, NCT05547152 is actively recruiting participants. Contact the research team at sarhan.francois-regis@chu-amiens.fr for enrollment information.
Where is the NCT05547152 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05547152 clinical trial?
NCT05547152 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 100 participants.
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