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Clinical Trials/ACTRN12622000838718
ACTRN12622000838718
Not yet recruiting
未知

The Efficacy of Microvascular Decompression for Unilateral Pulsatile Tinnitus- A Prospective Randomised Multicenter Study

Monash Health0 sites30 target enrollmentJune 15, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Monash Health
Enrollment
30
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 15, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • The inclusion criteria are as follows: 1\) age 18\-75 years; 2\) unilateral pulsatile tinnitus with some preservation of ipsilateral hearing; 3\) MRI brain with no alternative major abnormality accounting for symptoms and there is identifiable vascular compression of the vestibulocochlear nerve; 4\) all conservative therapies have been trialled and exhausted without significant symptom relief; 5\) pre\-op assessment by audiometry, vestibular testing and assessment by either a consultant ENT surgeon or Neurosurgeon who deem that microvascular decompression (MVD) is indicated; 6\) patients with an American Society of Anaesthiology (ASA) score of I/II; and 7\) patients have suffered from pulsatile tinnitus for \>12 months

Exclusion Criteria

  • The exclusion criteria are as follows: 1\) non\-pulsatile tinnitus; 2\) bilateral tinnitus; 3\) abnormal MRI brain with significant structural abnormality; 4\) previous retrosigmoid craniotomy or radiotherapy to the posterior fossa of the brain; 5\) severe medical co\-morbidities with ASA score III/IV; 6\) patients with psychiatric comorbidity; 7\) total deafness; and 8\) inability to consent.

Outcomes

Primary Outcomes

Not specified

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