search
Back to results

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
Rebecka Ohm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Paralysis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 7, 2021
Last Updated
October 5, 2023
Sponsor
Rebecka Ohm
search

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