None listed
Conditions
Brief summary
Tinnitus is a common presentation whereby patients experience a ringing or buzzing sound in the absence of external noise, and these symptoms can be quite debilitating for the affected individual. Pulsatile tinnitus represents a subtype that may be caused by compression exerted by an arterial loop or vein against the vestibulocochlear nerve as it exits the brainstem en-route to the inner ear. Microvascular decompression (MVD) is already routinely performed for the treatment of other neurovascular compression syndromes with positive results, including trigeminal neuralgia (compression of trigeminal nerve), hemifacial spasm (compression of facial nerve) and glossopharyngeal neuralgia (compression of the glossopharyngeal nerve). There is a limited volume of worldwide literature which suggests that surgery (microvascular decompression of the acoustic nerve) to treat this condition may be of benefit in selected cases. The evidence is limited to small case series, and several systematic reviews, but no randomised trials have been performed to date. The objective of this study is to go beyond what we already know from the limited literature by carrying out a randomized multi-centre controlled trial, investigation to results of microvascular decompression of the acoustic nerve. The primary endpoint is treatment efficacy compared to control. The secondary endpoints examine the safety and prognostic factors that would lead to a more favourable outcome following surgery. A small case series of patients recruited from two large health networks in Melbourne (Melbourne Health and Monash Health) will be selected according to the type and severity of their tinnitus. Inclusion criteria include: 1) patients with unilateral pulsatile tinnitus, 2) there is an identifiable compression of their vestibulocochlear nerve by an arterial loop or vein on pre-operative imaging, 3) have suffered from pulsatile tinnitus for > 12 months, 4) have attempted other conservative measures, 5) age 18-75 years and 6) able to consent for participate in the study. Patients meeting the inclusion criteria and who consent to participation in the study will be randomised to either continue with 1) best medical management (control arm) or 2) undergo microvascular decompression via a retrosigmoid craniotomy at either of the two study centres (intervention arm). This surgery involves a general anaesthetic, and posterior fossa craniotomy, identification of the vestibulocochlear nerve and compressing vessel, and removing this vessel away from the nerve to relieve the pressure on it. The primary outcome measure is the surgical efficacy for treating pulsatile tinnitus. Based off the existing literature, it is hypothesised that at least 60% of participants will experience some symptom relief post-surgery.
Interventions
Participants with unilateral pulsatile tinnitus, secondary to vascular compression and without any other identifiable cause, and have exhausted maximal medical therapy, will be eligible for enrolment. This trial will consist of two groups - a control and an intervention group. Participants will be randomised to either group.
The intervention group will consist of participants undergoing surgery in the form of microvascular decompression of the hearing nerve (vestibulocochlear nerve). Microvascu
Participants with unilateral pulsatile tinnitus, secondary to vascular compression and without any other identifiable cause, and have exhausted maximal medical therapy, will be eligible for enrolment. This trial will consist of two groups - a control and an intervention group. Participants will be randomised to either group. The intervention group will consist of participants undergoing surgery in the form of microvascular decompression of the hearing nerve (vestibulocochlear nerve). Microvascular decompression is already an established surgical treatment for patients with trigeminal neuralgia (vascular compression of trigeminal nerve), hemifacial spams (vascular compression of facial nerve) and glossopharyngeal neuralgia (vascular compression of glossopharyngeal nerve). Microvascular decompression of the vestibulocochlear nerve has been described in the literature with promising results, although large scale trials have never been performed. This trial aims to go beyond what exists in the literature by being the first randomised study to investigate the efficacy of microvascular decompression for pulsatile tinnitus. If found to be effective in providing symptom relief, then this will offer patients affected with this condition with another line of treatment. Participants in this group will continue receiving maximal medical therapy as they were previously (e.g. CBT, masking devices or hearing aids), and this will continue for the duration of this study i.e. for 90 days post-op and beyond. The surgery will be performed by both and ENT and Neurosurgeon as a joint procedure, and will take 2-3hrs. Intra-operatively, the offending vessel (artery or nerve) compressing the vestibulocochlear nerve will be separated. Participants will still continue to receive maximal medical therapy for the duration of the trial, without interruption. Operation reports will be audited by the investigators.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed