Effects of Endolymphatic Sac Drainage With Steroids for Meniere's Disease

NCT ID: NCT00500474

Last Updated: 2007-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-04-30
• Study Completion Date: 2005-03-31

Brief Summary

Meniere's disease is a common inner ear disease with an incidence of 15-50 per 100,000 population. Since Meniere's disease is thought to be triggered by an immune insult to inner ear, we examined intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere's disease.

Detailed Description

Meniere's disease characterized by recurrent attacks of vertigo, fluctuating hearing loss and tinnitus, is a common disease with an incidence of 15-50 per 100,000 population. Some patients with Meniere's disease are strongly prevented from participating in activities of daily life and interaction with their social environment, such as work and schooling, due to frequent attacks of vertigo especially with progressive sensorineural hearing loss, in spite of various kinds of medication. This type of Meniere's disease is called intractable Meniere's disease. Although the oto-pathology in Meniere's temporal bones was revealed in 1938 to be inner ear endolymphatic hydrops, the definitive pathogenesis of Meniere's disease is still unknown and there is no radical treatment for this disease.

It has, however, been reported that Meniere's disease is usually triggered by immune, metabolic, infectious, traumatic or other insults to the inner ear, associated with a small misplaced malfunctioning endolymphatic sac. Among these insults, immune-mediated responses in the inner ear endo-organs such as the endolymphatic sac, stria vascularis and spiral ligament, are thought to be the main reason for the development of symptoms in Meniere's disease. Thus, systemic administration and/or local perfusion of corticosteroids into the middle ear have been adopted as an anti-immune or anti-inflammatory therapy for patients with intractable Meniere's disease. These treatments were reported to result in good relief from vertigo and improvement of hearing in some cases. However, these results especially for hearing did not last long enough to discontinue additional repetitive applications of steroids. Since Meniere's disease is characterized by repeated attacks of vertigo with fluctuating and/or progressive hearing loss unlike other inner ear diseases without recurrence such as sudden deafness and vestibular neuritis, it is necessary to refrain from repetitive applications of steroids for the long-term follow-up with Meniere's patients because of side effects.

For inner ear drug delivery, we noted another hopeful but unevaluated route, the longitudinal route from the endolymphatic sac to the cochlea and vestibule, suggested by several lines of evidence in animal studies. Morgenstern et al. and Lee et al. demonstrated that the intra-endolymphatic sac materials could reach the cochlear endolymphatic site through the vestibular aqueduct using a test marker and an oto-toxic drug, respectively. Recently, Yamasoba et al. suggested the possibility of gene therapy through the vestibular aqueduct route. We also revealed that intra-endolymphatic sac steroids could up-regulate a water channel molecule, aquaporin-3 mRNA in the cochlea.

In the present study, we examined the intra-endolymphatic sac application of large doses of steroids as de novo treatment for intractable Meniere's disease.

Conditions

Meniere's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

endolymphatic sac drainage with steroids

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of Meniere's Disease, who did not respond to various forms of medical and psychological managements for at least 6 months, i.e. intractable Meniere's disease.

Exclusion Criteria

• Other known causes of vertigo including central lesion

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osaka University

OTHER

Sponsor Role: lead

Principal Investigators

Tadashi Kitahara, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Otolaryngology, Osaka University, School of Medicine

Locations

Department of Otolaryngology, Osaka University, School of Medicine

Suita, Osaka, Japan

Countries

Japan

References

Kitahara T, Fukushima M, Uno Y, Mishiro Y, Kubo T. Up-regulation of cochlear aquaporin-3 mRNA expression after intra-endolymphatic sac application of dexamethasone. Neurol Res. 2003 Dec;25(8):865-70. doi: 10.1179/016164103771953989.

Reference Type: BACKGROUND

PMID: 14669532 (View on PubMed)

Kitahara T, Horii A, Imai T, Ohta Y, Morihana T, Inohara H, Sakagami M. Effects of endolymphatic sac decompression surgery on vertigo and hearing in patients with bilateral Meniere's disease. Otol Neurotol. 2014 Dec;35(10):1852-7. doi: 10.1097/MAO.0000000000000469.

Reference Type: DERIVED

PMID: 24979126 (View on PubMed)

Other Identifiers

tk20090401

Identifier Type: -

Identifier Source: secondary_id

tk19661217

Identifier Type: -

Identifier Source: org_study_id