An auditory brainstem implant for treatment of unilateral tinnitus: protocol for an interventional pilot study.
Minke J C van den Berge, J M C van Dijk, Jan D M Metzemaekers...
https://pubmed.ncbi.nlm.nih.gov/31201186Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID02630589
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
Led by University Medical Center Groningen · Updated on 2024-02-13
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Medical Center Groningen
Lead Sponsor
M
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Tinnitus is the perception of sound without an external source and affects many people, often severely impacting quality of life. This research evaluates the use of an auditory brainstem implant (ABI) to reduce severe, unilateral tinnitus when other treatments have failed. Unlike cochlear implants, the ABI is designed not to damage inner ear structures, making it a promising option. This pilot study involves 10 adult patients with severe tinnitus and hearing loss on the affected side. All participants will receive an ABI surgically implanted via a retrosigmoid transcranial approach, with the electrode placed on the cochlear nucleus. The implant will be switched on six weeks after surgery. The procedure requires a hospital stay of about four days, followed by outpatient visits for device fitting and monitoring. This study does not include a control group and focuses on assessing the ABI's effects as well as safety for this new use. Patients will be followed for up to five years after implantation, with regular assessments including the Tinnitus Functioning Index, audiometry tests, tinnitus evaluations, vestibular tests, anxiety and depression scales, and device-related outcomes. Follow-up visits occur frequently in the first year and less often thereafter. The study monitors both the impact on tinnitus and hearing, along with potential complications from surgery and device use.
CONDITIONS
Brief Title
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Unilateral tinnitus
- Severely invalidating tinnitus
- Men or women aged over 18 years
- Tinnitus present for more than 1 year and stable during the last year
- Tinnitus not responsive to conventional treatments like hearing aids and cognitive behavioral therapy
- Ipsilateral ear has pure tone audiometry thresholds over 40dB and under 90dB (mean over 1-2-4kHz)
- Contralateral ear has functional hearing with pure tone audiometry thresholds under 35dB (mean over 1-2-4 kHz) and at least 25dB better than the ipsilateral ear
- Able to give informed consent after full information about surgery and risks
You will not qualify if you...
- Detectable cause for tinnitus requiring specific treatment (e.g., vestibular schwannoma, glomus tumor, otosclerosis, arteriovenous malformation)
- Psychiatric disorders or unstable psychological condition
- Unrealistic expectations as judged by investigator or psychiatrist
- Life expectancy less than 5 years
- History of blood coagulation disorders
- ASA classification greater than II
- Pregnancy
- Anatomical abnormalities preventing placement of the implant or stimulator housing
- Known intolerance to implant materials (silicone, platinum, iridium, parylene C)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Hospital stay of about 4 days
Participants undergo neurosurgical implantation of the auditory brainstem implant (ABI) and hospital admission for approximately 4 days.
1 hospital admission
Treatment
Duration - Starts 6 weeks after implantation and continues as needed
The ABI device is activated 6 weeks after implantation and participants receive fitting sessions to adjust the device settings.
At least 8 outpatient visits in the first year for fitting sessions
Follow-up
Duration - Up to 5 years after implantation
Participants are followed for safety and efficacy assessments of tinnitus suppression and hearing function up to 5 years after implantation.
Regular assessments at 3 months, 6 months, 1 year, and annually up to 5 years after implantation
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Actively Recruiting
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here