Surgical treatment for facial movement issues after Bell's palsy
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
NA · Karolinska University Hospital · NCT05191719
This study is testing if a surgical procedure called neurotomy can help people with severe facial movement issues after Bell's palsy feel better when Botox hasn't worked for them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05191719 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of neurotomy as an alternative to Botox injections for patients suffering from severe synkinesis following peripheral facial palsy. Participants who have not found relief from Botox treatments will undergo a surgical procedure where problematic branches of the facial nerve are identified and separated from healthy ones. The study will assess outcomes through clinical evaluations, neurophysiological measurements, and quality of life questionnaires at multiple time points over a year. The aim is to determine if neurotomy can provide better results than the current standard treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals with severe synkinesis following peripheral facial palsy who have not responded satisfactorily to Botox injections.
Not a fit: Patients who have had synkinesis for less than two years or have other severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer significant improvement in facial function and quality of life for patients with severe synkinesis.
How similar studies have performed: While neurotomy is a novel approach for this specific condition, similar surgical interventions have shown promise in treating other nerve-related issues.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Synkinesis following peripheral facial palsy * Sunnybrook score \<61 * Botox injections at least 3 times a year * Have received at least 3 Botox injections * Botox injections not satisfying treatment * Read and signed written consent Exclusion Criteria: * Synkinesis since less than 2 years * Contractures in facial muscles * Other planned surgery in the face during study period * Smoking * Uncontrolled hypertension * Diabetes mellitus * Pregnancy or breast feeding * Severe systemic disease (ASA 3-4)
Where this trial is running
Stockholm
- Karolinska University Hospital/Karolinska Institute — Stockholm, Sweden (RECRUITING)
Study contacts
- Principal investigator: Birgit Stark, MD, PhD — Karolinska Institute/Karolinska University Hospital
- Study coordinator: Rebecka Ohm, MD, PhDStud.
- Email: rebecka.ohm@regionstockholm.se
- Phone: +4651770000
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: Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy, Synkinesis