Intratympanic Stereoidal Injections for Facial Nerve Palsy

Bell Palsy Clinical Trial

Official title:

Intratympanic Stereoidal Injections for Facial Nerve Palsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03371589
• Other study ID #: 0057-17
• Status: Not yet recruiting
• Phase: N/A
• First received: May 29, 2017
• Last updated: January 24, 2018
• Start date: February 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2018
• Source: Hillel Yaffe Medical Center
• Contact: Adi Klein, MA
• Phone: +972-6304169
• Email: adik[@]hy.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bell Palsy
• Facial Nerve Diseases
• Facial Paralysis
• Paralysis

Intervention

Drug:
• Dexamethasone
Solution for otic injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	House brackman scale	grade 1-6	change in score 1 month, 3 months and 6 months after end of treatment
Secondary	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