Intratympanic Stereoidal Injections for Facial Nerve Palsy

Bell's palsy is defined as a facial nerve palsy without any other known cause. The common practice for this disease consists of the use of oral steroids. Such treatment can cause harm to people who have disabilities or prior conditions such as pregnancies, diabetes, obesity and/or high blood pressure. While the use of intratympanic injection for sudden sensory hearing loss is well rehearsed in many practices, similar management of facial nerve palsy due to Bell's phenomenon is rare and a few researches have been conducted regarding the subject. In this research we suggest intratympanic injections for these patients as a treatment for Bell's palsy.

Study Overview

• Status: Unknown
• Conditions: Bell Palsy
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

Bell's palsy is defined as a facial nerve paralysis without any other known diagnosis or cause .Its' estimated occurrence is in 20 to 30 people per 100,000 people per year. The occurence is greater in patients older than 65 years old and lower in children younger than 13 years old. There are many estimated etiologies for Bell's palsy, such as failure of the vasa nervosa, viral infections, ischemic neuropathies and auto immune reactions. Of those, viral hypothesis is the most widely accepted.

The prognosis for recovery for most patients is 80% to 90%. One series showed that only 17 out of 1505 patients demonstrated moderate to severe sequela and none had complete facial nerve paralysis. The common practice for the management of Bell's palsy consists of oral steroids with or without the antiviral medications. A recent study made by the Department of Otorhinolaryngology and Head and Neck surgery in Korea indicated that Intratympanic injections could replace the use of oral steroids . Another recent study by Jong job lee et al. has shown that Intratympanic injections have prolonged uptake in rats, in comparison to Intraperitoneal injections.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Adult patients 18 years old or more, diagnosed with Bell's palsy who cannot receive oral steroid treatment for their condition, due to to pregnancy, diabetes, high blood pressure etc.

Exclusion Criteria:

• Children under the age of 18.
• Patients who can receive oral steroid treatment for their condition.
• Patients with internal ear problems. * Patients who already recieved treatmetn for their condition.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: no P.O corticosteroids; Steroids injection	Drug: Dexamethasone; Solution for otic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
House brackman scale	grade 1-6	change in score 1 month, 3 months and 6 months after end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nottingham scale for facial palsy	ratio (distance between point in the face in cm)	change in score 1 month, 3 months and 6 months after end of treatment

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Muhamad Taha, MD, Hillel Yaffe MC

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 24, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Bell Palsy; Facial Paralysis; Facial Nerve Diseases; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 0057-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No