A Phase 2/3 interventional study of Intratympanic injection and Prednisone in Bell's Palsy and Facial Nerve Paresis, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-05.
Sponsored by University of Missouri-Columbia · Phase 2/3, Interventional, and Treatment
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.
Facial nerve paralysis is due to inflammation surrounding the facial nerve. Current clinical practice guidelines for treatment of facial nerve paralysis recommend a 10 day course of oral steroids +/- oral acyclovir. Treatment should begin within 72 hours of symptom onset. In patients with complete facial paralysis, electrodiagnostic testing should be offered to the patient (1-2). In patients with 90% degeneration on electroneuronography (ENoG) testing, facial nerve decompression may be considered but is not a current recommendation.
In 1973, Bryant reported on ten cases where intratympanic steroid injection was used for the treatment of Bell's palsy (3). All but one of these patients had complete recovery of their facial nerve function. The remaining patient had 75% recovery. None of these patients suffered complications from the injections. The next study published on intratympanic steroid injection for Bell's palsy was not published until 2014 (4). It was a randomized control trial that divided patients into standard treatment (oral steroids and acyclovir) versus standard treatment with intratympanic steroid injection. There was not a statistically significant difference between the complete recovery rate of the control group and of the intratympanic steroid group; however, the time to recovery was significantly shorter in the intratympanic steroid injection group as compared to the control group. Limitations of this study include small sample size and high attrition rate.
There have not been any other studies published in the literature looking at improving facial nerve recovery in idiopathic facial nerve paralysis with the use of intratympanic steroid injections.
Exclusion Criteria:
Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper
Drug: Prednisone
Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.
Procedure: Intratympanic injection · Drug: Prednisone
Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks
Procedure: Intratympanic injection
Injection will be up to 1cc of dexamethasone 24mg/mL. The procedure will be performed at supine position under a microscope. Local anesthesia will be achieved with topical phenol. A myringotomy will be made in the tympanic membrane. A 1 mL syringe connected to a needle will be used to slowly inject between 0.2 cc and 1.0 cc of solution through the myringotomy, with the subject's head turned 45 degrees to the opposite side. The subject will be asked to maintain positioning for at least 30 minutes and refrain from swallowing. The dose administered will vary due to subject-specific factors.
Oral Steroid
Also known as: Prednisolone
Facial Nerve Recovery
Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1
Time frame: Up to 365 days
| Milestone | Standard of Care | SOC + Injection | Injection Only |
|---|---|---|---|
| Started | 1 | 9 | 0 |
| Completed | 1 | 9 | 0 |
| Not completed | 0 | 0 | 0 |
Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1
| Days | Standard of Care | SOC + Injection | Injection Only |
|---|---|---|---|
| Facial Nerve Recovery | 7 ± 0 | 81.56 ± 47.671 | — |
Collected over For each patient, AE's were collected from the time of informed consent until complete facial nerve paralysis recovery or one year post-treatment, whichever comes first. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| SOC + Injection | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Injection Only | — | — | — |
Injection only was for participants who could not, for medical reasons, receive the SOC treatment. We did not have any patients that met that criteria
| Age, Continuous(Years) | Standard of Care | SOC + Injection | Injection Only | Total |
|---|---|---|---|---|
| Mean | 63 ± 0 | 52.90 ± 13.836 | — | 52.90 ± 13.836 |
| Sex: Female, Male(Participants) | Standard of Care | SOC + Injection | Injection Only | Total |
|---|---|---|---|---|
| Female | 1 | 2 | — | 3 |
| Male | 0 | 7 | — | 7 |
| Race and Ethnicity Not Collected(Participants) | Standard of Care | SOC + Injection | Injection Only | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Standard of Care | SOC + Injection | Injection Only | Total |
|---|---|---|---|---|
| United States | 1 | 9 | — | 10 |
| House Brackman Score at Diagnosis(units on a scale) | Standard of Care | SOC + Injection | Injection Only | Total |
|---|---|---|---|---|
| Mean | 5 ± 0 | 5.11 ± 0.928 | — | 5.10 ± 0.876 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Not applicable...we do not plan to share individual participant data with other researchers so that we can maintain the privacy of our participants.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Missouri-Columbia