ACTRN12622000838718Not yet recruiting未知
The Efficacy of Microvascular Decompression for Unilateral Pulsatile Tinnitus- A Prospective Randomised Multicenter Study
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Monash Health
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
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.
Investigators
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