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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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bell Palsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 29, 2017
    Last Updated
    January 24, 2018
    Sponsor
    Hillel Yaffe Medical Center
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    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

    Learn more about this trial

    Intratympanic Stereoidal Injections for Facial Nerve Palsy

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