Intratympanic Steroid for Bell's Palsy

NCT ID: NCT03508440

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2023-06-01

Brief 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.

Detailed Description

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.

Conditions

Bell's Palsy; Facial Nerve Paresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Oral steroids (prednisone or prednisolone) 60mg per day for 10 days or 60mg/day for 5 days followed by a 5 day taper

Group Type: ACTIVE_COMPARATOR

Prednisone

Intervention Type: DRUG

Oral Steroid

SOC + injection

Oral steroids as described above + intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks.

Group Type: EXPERIMENTAL

Intratympanic injection

Intervention Type: 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

Intervention Type: DRUG

Oral Steroid

Injection only

Only Intratympanic injection of dexamethasone (up to 1cc of 24mg/ml) - 3 injections over three weeks

Group Type: OTHER

Intratympanic injection

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Prednisone

Oral Steroid

Intervention Type: DRUG

Other Intervention Names

Prednisolone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Arnaldo L. Rivera

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arnaldo Rivera, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2007139

Identifier Type: -

Identifier Source: org_study_id