Intratympanic Stereoidal Injections for Facial Nerve Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03371589
Recruitment Status : Not yet recruiting
First Posted : December 13, 2017
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Bell Palsy 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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Patients who cannot receive the oral treatment due to a prior condition e.g. diabetes, high blood pressure, pregnancy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intratympanic Stereoidal Injections for Facial Nerve Palsy
Anticipated Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: no P.O corticosteroids
Steroids injection
Drug: Dexamethasone
Solution for otic injection

Primary Outcome Measures :
  1. House brackman scale [ Time Frame: change in score 1 month, 3 months and 6 months after end of treatment ]
    grade 1-6

Secondary Outcome Measures :
  1. Nottingham scale for facial palsy [ Time Frame: change in score 1 month, 3 months and 6 months after end of treatment ]
    ratio (distance between point in the face in cm)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03371589

Contact: Adi Klein, MA +972-6304169

Sponsors and Collaborators
Hillel Yaffe Medical Center
Principal Investigator: Muhamad Taha, MD Hillel Yaffe MC

Responsible Party: Hillel Yaffe Medical Center Identifier: NCT03371589     History of Changes
Other Study ID Numbers: 0057-17
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Bell Palsy
Facial Paralysis
Facial Nerve Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents