NCT07295288

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

Not yet recruiting Phase 4 Last updated 15 April 2026

What this trial tests

Phase 4 trial testing Botulinum Toxin Type A Injection [Botox] in Synkinesis in 50 participants. Not yet recruiting.

Timeline

1 July 2026

Primary endpoint
30 June 2027

30 June 2027

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 4
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	1 July 2026
Primary completion	30 June 2027
Estimated completion	30 June 2027

Drugs / interventions tested

• Botulinum Toxin Type A Injection [Botox] — full drug profile →

Conditions studied

• Synkinesis — all drugs for Synkinesis →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Synkinesis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.