The Efficacy of Steroid Therapy in Vestibular Neuritis

Vestibular Neuritis Clinical Trial

Official title:

The Efficacy of Steroid Therapy in Vestibular Neuritis Confirmed by Head Impulse Test: Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098330
• Other study ID #: SVNHIT_kr
• Status: Completed
• Phase: Phase 3
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to compare the treatment effectiveness of steroid therapy for vestibular neuritis by using video head impulse test.

Description:

This study was a prospective, randomized controlled study. The enrolled vestibular neuritis patients were randomized to conservative treatment or steroid treatment when they are diagnosed with caloric test. After initial vestibular work-up including caloric, video head impulse tests, and a questinnaire (DHI), the patient was examined with the same tests again at 6 months later. The efficacy of steroid for the patients with vestibular neuritis would be determined by the comparison of the data of each group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ages over 18 years

• Acute vertigo that occurred within 7 days

• The spontaneous nystagmus should be detected

• Caloric weakness over 20%

Exclusion Criteria:

• Suspicious or verified a central nervous system lesion

• If the patient has denied.

• Other otologic disease (acute/chronic otitis media, otosclerosis, etc)

• The patient with history of otologic surgery

• The patient with history of brain surgery

Related Conditions & MeSH terms

• Neuritis
• Vestibular Neuritis
• Vestibular Neuronitis

Intervention

Drug:
• Ginkgo biloba & Methylprednisolone
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. Methylprednisolone 48 mg/day(per oral, once a day for first 9 days. And then methylprednisolone tapering was started every 2 days. The entire duration of methylprednisolone treatment was 14 days.
• Ginkgo biloba
Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Songpa-gu

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement in vestibular function test (caloric & videop HIT) after treatment	The effectiveness of steroid therapy was determined by comparing the improvement of vestibular function (the degree of canal paresis by caloric test; gain and presence of refixation-saccade by video HIT test).	The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.
Secondary	The improvement in dizziness handicap inventory after treatment	The effectiveness of steroid therapy was determined by comparing improvement of subjective symptoms (symptom score by DHI) in each group.	The first results were collected at initial diagnosis. And following results were collected 6 months after the first exam.