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Botox beyond the face: could jaw injections ease synkinesis?

NCT ID NCT07295288

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding Botox injections to the jaw (masseter) and temple (temporalis) muscles can improve symptoms of facial synkinesis—a condition where facial muscles move involuntarily after nerve injury. Fifty adults will receive standard Botox treatment alone or with extra injections into these non-facial muscles, using a crossover design so each person acts as their own control. The goal is to see if this approach reduces unwanted movements, headaches, and jaw tightness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Botulinum Toxin Type A (Botox)
What this could lead to
If it works, this could offer a simple addition to standard Botox treatment to better manage unwanted facial movements and related jaw pain or headaches.
What could go wrong
This is a small, early-phase study (50 people) testing an off-label use. The added benefit may be small or not apply to everyone, and there is a risk of temporary muscle weakness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Able to read and understand English. * Symptoms of neck tightness, jaw tightness, or headaches. Exclusion Criteria: * Cognitive impairment that would preclude the ability to provide informed consent * Unable to read text on a written survey or computer screen

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Conditions

The condition(s) this trial relates to.

Synkinesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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  2. A doctor treating you

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