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Botox Injections in Non-Cranial Nerve VII Innervated Muscles for Facial Synkinesis

StatusNot Yet Recruiting
PhasePhase 4
Started2026-07-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-12
critical
Study Status v2
Primary completion pushed: 2026-06-30 → 2027-06-30
Completion pushed: 2026-06-30 → 2027-06-30
Start date2026-02-01→2026-07-01
2025-12-20
minor
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2025-12-07
minor
Original filing
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.
Trial Details
NCT Number NCT07295288
Lead Sponsor Vanderbilt University Medical Center
Conditions Synkinesis
Enrollment 50 participants
Start Date 2026-07-01
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-15