Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Facial Paralysis
- Sponsor
- Rebecka Ohm
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Sunnybrook facial grading scale
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate neurotomy as an alternative treatment to Botox injections for severe synkinesis following peripheral facial palsy
Detailed Description
Patients with severe synkinesis treated at Karolinska University Hospital with Botox injections with unsatisfying results are invited to participate in this study aiming to evaluate surgical neurotomy to synkinesis causing branches of the facial nerve. Surgical procedure: Small branches of the facial nerve are identified under microscopic magnification. Using a precise nerve stimulator the movement each nerve branch elicits is evaluated as normal or synkinetic. Pathological branches are then parted while normal functioning nerve branches are left intact. Evaluation procedure: Study participants are measured in a multimodal manner at 5 different time points during the study period; at study start, with and without Botox effect before surgery, and at 6 and 12 months after surgery. Evaluation methods: * Clinical evaluation with Sunnybrook facial grading scale, blinded to observer from video recordings at the end of the study * Neurophysiological measurements, * Quality of life, measured with validated questionnaires FaCE, FDI, SAQ * Reports of potential side effects, using Clavien-Dindo classification as well as free text
Investigators
Rebecka Ohm
Birgit Stark, MD, associate professor
Karolinska University Hospital
Eligibility 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
- •Uncontrolled hypertension
- •Diabetes mellitus
- •Pregnancy or breast feeding
- •Severe systemic disease (ASA 3-4)
Outcomes
Primary Outcomes
Sunnybrook facial grading scale
Time Frame: Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Improvement through less synkinesis and better voluntary movement
Secondary Outcomes
- Side effects(Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery)
- Neurophysiological examination, electromyography (EMG).(4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery)
- Quality of life questionnaire(4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery)
- Number of Botox injections(Baseline, 12 months after surgery)