NCT02630589

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jul 2016Jan 2028

First Submitted

Initial submission to the registry

December 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

11.5 years

First QC Date

December 3, 2015

Last Update Submit

February 12, 2024

Conditions

Tinnitus

Keywords

tinnitusauditory brainstem implantelectrical stimulation

Outcome Measures

Primary Outcomes (1)

  • Tinnitus Functioning Index (TFI)

    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

    pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative

Secondary Outcomes (7)

  • Pure tone audiometry

    pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative

  • Tinnitus Handicap Inventory (THI)

    pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative

  • Vestibular test

    pre-op, 3 months postoperative

  • Visual Analogue Score (VAS)

    pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative

  • Hospital anxiety and depression scale (HADS)

    pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative

  • +2 more secondary outcomes

Study Arms (1)

ABI implantation

EXPERIMENTAL

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

Interventions

Auditory brainstem implantDEVICE

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.

Also known as: ABI
ABI implantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

Related Publications (1)

  • van den Berge MJC, van Dijk JMC, Metzemaekers JDM, Maat B, Free RH, van Dijk P. An auditory brainstem implant for treatment of unilateral tinnitus: protocol for an interventional pilot study. BMJ Open. 2019 Jun 14;9(6):e026185. doi: 10.1136/bmjopen-2018-026185.

    PMID: 31201186DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Auditory Brain Stem Implants

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural ProsthesesImplantable NeurostimulatorsElectrodes, ImplantedElectrodesElectrical Equipment and SuppliesEquipment and SuppliesProstheses and ImplantsHearing AidsSensory Aids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. P. van Dijk

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 15, 2015

Study Start

July 1, 2016

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

NL(1)