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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
Sponsor:
Collaborator:
MED-EL Elektromedizinische Geräte GesmbH
Information provided by (Responsible Party):
Minke van den Berge, University Medical Center Groningen

Brief Summary:
Tinnitus is the perception of sound or noise in the absence of an external physical source. It is a highly prevalent condition and for a high percentage of patients, there is no satisfying treatment modality. For some people, tinnitus has a very severe impact on quality of life, leading to incapacity for work and sometimes even suicidality. The auditory brainstem implant (ABI) is an implant indicated for the restoration of hearing in patients with an hypo-, or aplasia of the cochlear nerve or with dysfunction of the nerve caused by tumor growth in neurofibromatosis type II. It has been shown that the standard intended effect of an ABI has reduction of tinnitus as a welcome side effect in about 66% of the cases. This is in analogy with the promising effect of a cochlear implant (CI) as a treatment for patients with unilateral tinnitus. In this study, the effect of an ABI on severely invalidating, unilateral, intractable tinnitus will be investigated. The ABI may have an advantage over the CI as tinnitus treatment, because CI-implantation leads to destruction of inner ear structures, leading to profound deafness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI for the primary aim of tinnitus reduction in an intervention pilot study. In total 10 patients with unilateral, intractable tinnitus and severe hearing loss in the ipsilateral ear, will be implanted with the ABI.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Auditory brainstem implant Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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


  2. 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.


  3. 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.


  4. 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.


  5. 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.


  6. Tinnitus analysis [ Time Frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative ]
    tinnitus tone matching in contralateral ear

  7. 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 (%).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral tinnitus
  • Severely invalidating tinnitus
  • Men or women, age >18yr
  • Tinnitus that is present >1 years and was stable during the last year
  • Tinnitus that is nonresponsive to indicated conventional existing treatments (hearing aids and cognitive behavioral therapy (CBT)). If a psychologist has indicated that CBT may ameliorate tinnitus complaints, the patient should have tried CBT for long enough time to reasonably argue that these treatments were not successful. This is the same for hearing aids.
  • Ipsilateral ear: pure tone audiometry (PTA) thresholds >40dB and <90dB (mean over 1-2-4kHz)
  • Functional hearing in the contralateral ear with pure tone audiometry thresholds <35dB (mean over 1-2-4 kHz) and with a minimum Δ25dB compared to the ipsilateral ear.
  • Informed consent after extensive oral and written information about the surgery, complications and the uncertain effect of the ABI on tinnitus

Exclusion Criteria:

  • Detectable cause for tinnitus that requires causal therapy (e.g. vestibular schwannoma, glomus tumor, otosclerosis, arteriovenous malformation) as investigated by radiological and otological examination
  • Psychiatric pathology and/or an unstable psychological situation as declared by a psychiatrist
  • Unrealistic expectations as declared by the investigator and/or psychiatrist
  • Life expectancy <5 years
  • History of blood coagulation pathology
  • ASA >II
  • Pregnancy
  • Anatomic abnormalities that would prevent appropriate placement of the stimulator housing in the bone of the skull
  • Anatomical abnormalities or surgical complications that might prevent placement of the Auditory Brainstem Implant Active Electrode Array
  • Known intolerance to the materials used in the implant (medical grade silicone, platinum, iridium and parylene C)

Information from the National Library of Medicine

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


Locations
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Netherlands
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         
Sponsors and Collaborators
University Medical Center Groningen
MED-EL Elektromedizinische Geräte GesmbH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Minke van den Berge, prof. P. van Dijk, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02630589     History of Changes
Other Study ID Numbers: ABI for tinnitus
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Minke van den Berge, University Medical Center Groningen:
tinnitus
auditory brainstem implant
electrical stimulation

Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms