Intratympanic Steroid for Bell's Palsy

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.

• Intratympanic injection (Procedure): 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.
• Prednisone (Drug), also known as Prednisolone: Oral Steroid

Primary outcomes

• Facial Nerve Recovery [Up to 365 days]: Time (in days) from the diagnosis or start of treatment to complete recovery of paralysis, defined as house brackman score of 1

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Facial Nerve Recovery (Primary), Mean, Days: Standard of Care 7 +/- 0; SOC + Injection 81.56 +/- 47.671; Injection Only

Adverse events

Time frame: 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

• Study Protocol and Statistical Analysis Plan (PDF, 2016-11-21)

• Arnaldo Rivera, MD, Principal investigator, University of Missouri-Columbia