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Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

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ClinicalTrials.gov Identifier: NCT05191719
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : April 25, 2022
Sponsor:
Information provided by (Responsible Party):
Rebecka Ohm, Karolinska University Hospital

Study Description
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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

Condition or disease Intervention/treatment Phase
Facial Paralysis Facial Palsy Peripheral Facial Palsy Peripheral Facial Paralysis Bell Palsy Synkinesis Procedure: Botox injection Procedure: Neurotomy Not Applicable

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Botox Procedure: Botox injection
Comparator, current gold standard

Procedure: Neurotomy
Surgical procedure
Experimental: Neurotomy Procedure: Botox injection
Comparator, current gold standard

Procedure: Neurotomy
Surgical procedure


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery ]
    Facial Clinimetric Evaluation Scale (FaCE)

  2. Quality of life questionnaire [ Time Frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery ]
    Facial Disability Index (FDI)

  3. Quality of life questionnaire [ Time Frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery ]
    Synkinesis Assessment Questionnaire (SAQ)

  4. Neurophysiological examination, electromyography (EMG). [ Time Frame: 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), just before surgery, 6 and 12 months after surgery ]
    Severity of synkinesis evaluation using EMG calculations (turns and root mean square (RMS)) compared to the healthy hemiface (reference).

  5. Number of Botox injections [ Time Frame: Baseline, 12 months after surgery ]
    Decrease to no future need

  6. Side effects [ Time Frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery ]
    Clavien-Dindo Classification

  7. Side effects [ Time Frame: Baseline, 2-4 weeks after Botox (max effect), 6 and 12 months after surgery ]
    Free text, in order to capture all possible side effects of treatments.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191719


Contacts
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Contact: Rebecka Ohm, MD, PhDStud. +4651770000 rebecka.ohm@regionstockholm.se

Locations
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Sweden
Karolinska University Hospital/Karolinska Institute Recruiting
Stockholm, Sweden
Contact: Rebecka Ohm         
Contact: Birgit Stark         
Sponsors and Collaborators
Rebecka Ohm
Investigators
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Principal Investigator: Birgit Stark, MD, PhD Karolinska Institute/Karolinska University Hospital
More Information
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Responsible Party: Rebecka Ohm, Birgit Stark, MD, associate professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT05191719    
Other Study ID Numbers: K2018-5656
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: April 25, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bell Palsy
Facial Paralysis
Paralysis
Synkinesis
Facies
Neurologic Manifestations
Nervous System Diseases
Disease Attributes
Pathologic Processes
 Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Infections
Mouth Diseases
Stomatognathic Diseases
Facial Nerve Diseases
Cranial Nerve Diseases
Dyskinesias