Intratympanic Stereoidal Injections for Facial Nerve Palsy
Primary Purpose
Bell Palsy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Bell Palsy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
no P.O corticosteroids
Arm Description
Steroids injection
Outcomes
Primary Outcome Measures
House brackman scale
grade 1-6
Secondary Outcome Measures
Nottingham scale for facial palsy
ratio (distance between point in the face in cm)
Full Information
NCT ID
NCT03371589
First Posted
May 29, 2017
Last Updated
January 24, 2018
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03371589
Brief Title
Intratympanic Stereoidal Injections for Facial Nerve Palsy
Official Title
Intratympanic Stereoidal Injections for Facial Nerve Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
August 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bell Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
no P.O corticosteroids
Arm Type
Experimental
Arm Description
Steroids injection
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Solution for otic injection
Primary Outcome Measure Information:
Title
House brackman scale
Description
grade 1-6
Time Frame
change in score 1 month, 3 months and 6 months after end of treatment
Secondary Outcome Measure Information:
Title
Nottingham scale for facial palsy
Description
ratio (distance between point in the face in cm)
Time Frame
change in score 1 month, 3 months and 6 months after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adi Klein, MA
Phone
+972-6304169
Email
adik@hy.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhamad Taha, MD
Organizational Affiliation
Hillel Yaffe MC
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Intratympanic Stereoidal Injections for Facial Nerve Palsy
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