NCT05191719

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

November 7, 2021

Last Update Submit

October 5, 2023

Conditions

Facial ParalysisFacial PalsyPeripheral Facial PalsyPeripheral Facial ParalysisBell PalsySynkinesis

Outcome Measures

Primary Outcomes (1)

  • Sunnybrook facial grading scale

    Improvement through less synkinesis and better voluntary movement

    Baseline, 4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 6 and 12 months after surgery

Secondary Outcomes (7)

  • Quality of life questionnaire

    4 months after Botox (no effect), 2-4 weeks after Botox (max effect), 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

  • Quality of life questionnaire

    4 months after Botox (no effect), 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

  • Number of Botox injections

    Baseline, 12 months after surgery

  • +2 more secondary outcomes

Study Arms (2)

Botox

ACTIVE COMPARATOR
Procedure: Botox injectionProcedure: Neurotomy

Neurotomy

EXPERIMENTAL
Procedure: Botox injectionProcedure: Neurotomy

Interventions

Botox injectionPROCEDURE

Comparator, current gold standard

BotoxNeurotomy
NeurotomyPROCEDURE

Surgical procedure

BotoxNeurotomy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital/Karolinska Institute

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Facial ParalysisBell PalsySynkinesis

Interventions

Botulinum Toxins, Type ADenervation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsFacial Nerve DiseasesCranial Nerve DiseasesDyskinesias

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Birgit Stark, MD, PhD

    Karolinska Institute/Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecka Ohm, MD, PhDStud.

CONTACT

+4651770000rebecka.ohm@regionstockholm.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Birgit Stark, MD, associate professor

Study Record Dates

First Submitted

November 7, 2021

First Posted

January 13, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

October 6, 2023

Record last verified: 2023-10

Locations

SE(1)