Intratympanic Stereoidal Injections for Facial Nerve Palsy

NCT03371589 | Unknown

• 1 other identifier: 0057-17
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bell Palsy

Outcome Measures

Primary Outcomes (1)

• House brackman scale

  grade 1-6

  change in score 1 month, 3 months and 6 months after end of treatment

Secondary Outcomes (1)

• Nottingham scale for facial palsy

  change in score 1 month, 3 months and 6 months after end of treatment

Study Arms (1)

no P.O corticosteroids

EXPERIMENTAL

Steroids injection

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Solution for otic injection

no P.O corticosteroids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

MeSH Terms

Conditions

Bell Palsy

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Muhamad Taha, MD

  Hillel Yaffe MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adi Klein, MA

CONTACT

+972-6304169; adik@hy.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Patients who cannot receive the oral treatment due to a prior condition e.g. diabetes, high blood pressure, pregnancy.

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: December 13, 2017
• Study Start: February 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 25, 2018

Record last verified: 2018-01