Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis
ConditionSynkinesis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
Facial synkinesis is a condition that occurs following facial nerve (CN7) injury, typically secondary to Bell's palsy, trauma, surgery (e.g., acoustic neuroma resection), or malignancy. Synkinesis is due to aberrant regeneration of the facial nerve, where axons regrow improperly and result in misdirected innervation of facial muscles. This results in involuntary, uncoordinated muscle movements, where activation of one muscle group triggers unintended contractions in others. Standard treatment of facial synkinesis involves botulinum toxin (BT) injections into muscles controlled by CN7 to reduce these unwanted movements. However, patients often anecdotally report that adding BT injections into non-CN7 innervated muscle groups, such as the masseter and temporalis muscles, improve their synkinesis symptoms. This study therefore aims to assess whether adding BT injections to non-CN7 innervated muscle groups, specifically the masseter and temporalis muscle, can improve treatment outcomes for people with facial synkinesis. This study will use a crossover design, where each participant will serve as their own control to compare treatment effects. In the first treatment arm, patients will receive only their standard BT injections into muscle groups controlled by CN7 - no other muscles will be treated. In the second treatment arm, will receive the same standard BT injections in CN7 muscles, plus additional injections into masseter and temporalis muscles. Patients will be randomized to a specific treatment arm at their first visit. At their second visit, they will be randomized to the other treatment arm, in standard crossover study design. Pre- and post-treatment surveys will be collected to assess the benefit of adding non-CN7 muscle groups.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18 years.
Current diagnosis of facial synkinesis due to facial nerve paralysis/paresis.
Scheduled to undergo BT injection for management of facial synkinesis.
Have undergone > 3 prior BT injection sessions at VUMC for facial synkinesis.
Disqualifiers
Cognitive impairment that would preclude the ability to provide informed consent
Unable to read text on a written survey or computer screen
Trial design
Design model
Crossover
Treatments tested in this trial
Botulinum Toxin Type A Injection [Botox]
DrugPatients will receive standard of care synkinesis treatment. Depending on the treatment arm, they will receive additional botox injections to temporalis and masseter muscle groups which will only be injected on the ipsilateral side to the facial nerve injury. Decision to include the temporalis and/or masseter muscles will be based on each patients response to screening questions regarding jaw pain/tightness or headaches.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Even MRNOther 1 intervention
Group B: Odd MRNOther 1 intervention
Trial outcomes
Primary outcomes
1
Synkinesis Assessment Questionnaire (SAQ)
This 9-item questionnaire assesses functional status (hyperactive and/or inappropriately active facial muscles) related to facial synkinesis and is already given at each clinic visit as a routine part of clinical practice. The survey is well validated for evaluating synkinesis symptoms in patients with facial nerve injury. SAQ scale: 1 = seldom or not at all, 2 = occasionally, or very mildly, 3 = sometimes, or mildly, 4 = most of the time, or moderately, 5 = all the time, or severely
Time frame
Pre-treatment and repeated 5 weeks post-treatment2
Headache Impact Test (HIT-6)
This 6-item questionnaire seeks to understand the severity of headaches and impact on every-day quality of life. The survey is widely validated for assessing headache symptom and burden. We plan to add in 3 additional questions to this survey including 1) how often do you experience headaches (1 = never or rarely, 2 = 1-2 days a week, 3 = 3-4 days a week, 4 = nearly every day), 2) on a scale of 1-10 (10 = most severe) how severe are your headaches, and 3) I feel as if my Botox injections improved my headaches (Y/N). HIT-6 Scale: 1 = Never 2 = Rarely 3 = Sometimes 4 = Very often 5 = Always
Time frame
Pre-treatment and repeated 5 weeks post-treatment3
Temporomandibular Disorder Questionnare (TMD-7)
This 7-item questionnaire assesses symptoms related to temporomandibular mandibular joint (TMJ) disorder. It asks about jaw pain, tightness, clicking and difficulty eating, among other things. We plan to add in 3 additional questions to this survey including 1) how often do you experience jaw pain/tightness (1 = never or rarely, 2 = 1-2 days a week, 3 = 3-4 days a week, 4 = nearly every day), 2) on a scale of 1-10 (10 = most severe) how severe is your jaw pain/tightness, and 3) I feel as if my Botox injections improved my jaw pain/tightness (Y/N). TMD-7 Scale: 1 = Rarely or Never 2 = A few times a month 3 = Once or Twice a Week 4 = Nearly Every Day
Time frame
Pre-treatment and repeated 5 weeks post-treatmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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