Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
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|ClinicalTrials.gov Identifier: NCT02630589|
Recruitment Status : Recruiting
First Posted : December 15, 2015
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Auditory brainstem implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2024|
Experimental: ABI implantation
All 10 patients included in the study will be neurosurgically implanted with the ABI. This is open label, not blinded. The implant is permanent, but can be switched off.
Device: Auditory brainstem implant
The ABI will be implanted by the neurosurgeon. The implant is fixed in a bed drilled in the parietal-temporal cortex, and the ABI electrode array is inserted into the lateral recess of the fourth ventricle and placed on the cochlear nucleus. Access to the cochlear nucleus will be made via retrosigmoid transcranial approach.
Other Name: ABI
- Tinnitus Functioning Index (TFI) [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]
Unit of measure: Items on a scale.
The TFI (tinnitus functioning index) is a questionnaire validated to detect changes in tinnitus outcome after an intervention
- Pure tone audiometry [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]
Unit of measure: Fletchers Index (mean of dB on 1-2-4 kHz on pure tone audiometry)
Change in hearing as a result of ABI implantation is measured by pure tone audiometry and speech audiometry
- Tinnitus Handicap Inventory (THI) [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]
Unit of measure: items on a scale
This validated questionnaire measures the effect of tinnitus on quality of life of the patient.
- Vestibular test [ Time Frame: pre-op, 3 months postoperative ]
Unit of measure: description of vestibular function ("afunctional", "normal functioning"
To establish an preoperative situation of both vestibular organs, a standard vestibular testing will be performed.
- Visual Analogue Score (VAS) [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]
Unit of measure: items on a scale.
The VAS (Visual analog scale) is a subjective measurement scale. Registration of VAS-scores gives the ability to quickly measure the aspects of the tinnitus complaints. It consists of a 100mm-horizontal line with 2 endpoints labeled as 0 and 10. The patient states on a scale from 0-10 how much patient is bothered by the complaint. The VAS-tinnitus annoyance (VAS-TA) was labeled as 0 (not annoyed by tinnitus) and 10 (worst possible annoyed by tinnitus). The VAS-tinnitus loudness (VAS-TL) was labeled as 0 (no tinnitus) and 100 (loudest tinnitus ever).(31). Also, the VAS-scores are measured at every follow up moment in 'on' and 'off' mode of the ABI (which will be blinded for the patient), with estimated 10 minutes between the measurements.
- Hospital anxiety and depression scale (HADS) [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]
Unit of measure: items on a scale.
The HADS (hospital anxiety and depression scale) is validated in Dutch consists of 14 items, each using a Likert scale (0-3), with subscales for anxiety (seven items) and depression (seven items).(30) The suggested cut-off score (with ranges of 0-21 for each subscale) for screening for possible cases is 8, and for probable cases of anxiety and depression 11. Time to complete the HADS is approximately 10-15.
- Tinnitus analysis [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]tinnitus tone matching in contralateral ear
- ABI-related outcomes [ Time Frame: at every change in ABI setting (minimum: switch on, 6 wk after switch on, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]Percentage of time that the ABI was used per day (%), logged days (%).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630589
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9700RB|
|Contact: Minke van den Berge, MSc +3153616161|
|Principal Investigator: Pim van Dijk, professor|
|Principal Investigator: Marc van Dijk, PhD|