CompletedPhase 2/3

Intratympanic Steroid for Bell's Palsy

United States10 participantsStarted 2018-01-31

Plain-language summary

Facial nerve paralysis is due to inflammation around the facial nerve. Current treatment for facial nerve paralysis is a 10 day course of oral steroids (which will reduce the inflammation), with electrodiagnostic testing. There have been limited studies on the use of intratympanic steroid injection, in addition to oral steroid, in the recovery of facial nerve paralysis. There are indications that the use of intratympanic injections, in addition to the oral steroids, will speed up the recovery rate of the facial nerve paralysis, as well as improve the complete recovery of the facial nerve paralysis. This study will randomize patients with facial nerve paralysis into two groups: 1) oral steroid only and 2) oral steroid plus a 3 intratympanic steroid injections spaced out over three weeks. There are a subset of patients that are unable to take oral steroids for medical reasons (such as diabetes); these patients will be placed into a third group and only receive 3 intratympanic steroid injections space out over three weeks. Subjects that are to receive the intratympanic injection will receive pre- and post-hearing exams as part of their standard of care. Patients will be evaluated via videorecording by two blinded investigators as well as in person evaluations by the unblinded treating physician. Subjects will be followed until complete facial nerve paralysis recovery or one year post-treatment, whichever comes first.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English as primary language * Acute unilateral facial palsy without skin lesions which developed within a 72-hour period and is present for 21 days or less. * Moderate to severe facial palsy \[House-Brackmann grade IV or greater\] Exclusion Criteria: * Another cause of facial nerve paralysis that is not idiopathic * Otologic disease including otitis media, temporal bone fracture, a previous history of facial nerve palsy in either side, history of otologic surgery, and suspected Ramsay Hunt syndrome. * Systemic disease including history of tuberculosis, history of head and neck cancer, other neurological disorders, recent use of ototoxic medications, liver or renal dysfunction, and other illnesses that would contraindicate the use of high-dose steroid therapy. * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Facial Nerve Recovery

Timeframe: Up to 365 days

Trial details

NCT IDNCT03508440

SponsorUniversity of Missouri-Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-22

Results submitted2024-07-26

View on ClinicalTrials.gov More Bell's Palsy trials