Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Primary Purpose
Facial Paralysis, Facial Palsy, Peripheral Facial Palsy
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Botox injection
Neurotomy
Sponsored by
About this trial
This is an interventional treatment trial for Facial Paralysis
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
- Smoking
- Uncontrolled hypertension
- Diabetes mellitus
- Pregnancy or breast feeding
- Severe systemic disease (ASA 3-4)
Sites / Locations
- Karolinska University Hospital/Karolinska InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Botox
Neurotomy
Arm Description
Outcomes
Primary Outcome Measures
Sunnybrook facial grading scale
Improvement through less synkinesis and better voluntary movement
Secondary Outcome Measures
Quality of life questionnaire
Facial Clinimetric Evaluation Scale (FaCE)
Quality of life questionnaire
Facial Disability Index (FDI)
Quality of life questionnaire
Synkinesis Assessment Questionnaire (SAQ)
Neurophysiological examination, electromyography (EMG).
Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference).
Number of Botox injections
Decrease to no future need
Side effects
Clavien-Dindo Classification
Side effects
Free text, in order to capture all possible side effects of treatments.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05191719
Brief Title
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Official Title
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecka Ohm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Paralysis, Facial Palsy, Peripheral Facial Palsy, Peripheral Facial Paralysis, Bell Palsy, Synkinesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
All study participants are evaluated with and without the effect Botox treatment before surgery. Botox is the gold standard treatment and used as a comparator. As all study patients have failed current evidence based treatment options, a comparative group not receiving treatment would imply a strong information bias.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
73 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botox
Arm Type
Active Comparator
Arm Title
Neurotomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Botox injection
Intervention Description
Comparator, current gold standard
Intervention Type
Procedure
Intervention Name(s)
Neurotomy
Intervention Description
Surgical procedure
Primary Outcome Measure Information:
Title
Sunnybrook facial grading scale
Description
Improvement through less synkinesis and better voluntary movement
Time Frame
Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Description
Facial Clinimetric Evaluation Scale (FaCE)
Time Frame
4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Title
Quality of life questionnaire
Description
Facial Disability Index (FDI)
Time Frame
4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Title
Quality of life questionnaire
Description
Synkinesis Assessment Questionnaire (SAQ)
Time Frame
4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Title
Neurophysiological examination, electromyography (EMG).
Description
Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference).
Time Frame
4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery
Title
Number of Botox injections
Description
Decrease to no future need
Time Frame
Baseline, 12 months after surgery
Title
Side effects
Description
Clavien-Dindo Classification
Time Frame
Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
Title
Side effects
Description
Free text, in order to capture all possible side effects of treatments.
Time Frame
Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Smoking
Uncontrolled hypertension
Diabetes mellitus
Pregnancy or breast feeding
Severe systemic disease (ASA 3-4)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecka Ohm, MD, PhDStud.
Phone
+4651770000
Email
rebecka.ohm@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgit Stark, MD, PhD
Organizational Affiliation
Karolinska Institute/Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital/Karolinska Institute
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecka Ohm
First Name & Middle Initial & Last Name & Degree
Birgit Stark
12. IPD Sharing Statement
Learn more about this trial
Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
We'll reach out to this number within 24 hrs