TinnitusNCT02630589
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
A study testing Auditory brainstem implant in people with Tinnitus, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- What is being tested?
- Auditory brainstem implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2016to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9700RB
Minke van den Berge, MSc, +3153616161
Pim van Dijk, professor
About this study
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.
Read the detailed description
Rationale: 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.
Objective. To evaluate the efficacy of an ABI for the suppression of unilateral, intractable tinnitus and to establish the safety of the ABI for this new indication.
Study design. This is a single center, non-randomized, prospective cohort, intervention pilot study. There is no control group. In this study, 10 patients will be implanted with an ABI.
Study population. Adult patients with invalidating, unilateral, intractable tinnitus and ipsilateral severe hearing loss are included in this study. All study participants have no significant comorbidity and are mentally competent.
Intervention. All study participants receive an ABI, which will be neurosurgically implanted. The ABI will be switched on 6 weeks after implantation. The surgery and post-surgery follow-up and switch-on procedures are consistent with the intended use of the ABI.
Main study parameters. The primary outcome is change in the Tinnitus Functioning Index (TFI). The endpoint is set at 1 year after implantation. Follow up will take place until 5 years after implantation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness. The implantation, activation and fitting of the ABI will be performed exactly as described in the existing protocols for intended use, however in this study, the ABI is placed for another indication. Implantation of the ABI requires hospital admission for estimated 4 days. After dismissal, patients visit the outpatient clinic at least 8 times in the first year, depending on the amount of fitting session necessary. Implantation of the ABI is an invasive procedure, which potentially can cause severe complications (meningitis 3,8%, transient hydrocephalus 1,3%, cerebellar contusion 1,2%). Other complication that may occur are infection, bleeding, hearing loss and other cranial nerve dysfunctions. By an extensive training program for the neurosurgeon and presence of the experienced surgeon during the first surgical procedures, the investigators feel that neurosurgical risks and risk of device failure due to inadequate implantation can be limited. In this pilot study, the effects on hearing and tinnitus are still uncertain, however based on the results published in literature the investigators are confident that the effects on both will be positive. Nonauditory side-effects and disappointing results on hearing and/or tinnitus can be well managed by altering stimulation strategy or if necessary, by turning off the device. Tinnitus can be severely invalidating with a large impact on quality of life and the ABI is promising in reducing tinnitus in these patients. This study imposes a significant risk on the study participants. However, the investigators feel that the risks outweighs the potential to ameliorate severely debilitating tinnitus.
- Conditions
- Tinnitus
- Being tested
- Auditory brainstem implant
- Keywords
- tinnitus, auditory brainstem implant, electrical stimulation
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory brainstem implantDevice
Also called ABI
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Auditory brainstem implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Secondary outcomes (7)
Pure tone audiometry
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
Measured: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Tinnitus Handicap Inventory (THI)
Unit of measure: items on a scale
This validated questionnaire measures the effect of tinnitus on quality of life of the patient.
Measured: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Vestibular test
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.
Measured: pre-op, 3 months postoperative
Visual Analogue Score (VAS)
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.
Measured: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Hospital anxiety and depression scale (HADS)
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.
Measured: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Tinnitus analysis
tinnitus tone matching in contralateral ear
Measured: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
ABI-related outcomes
Percentage of time that the ABI was used per day (%), logged days (%).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startJul 2016
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Responsible party
- Principal investigator, Minke van den Berge, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630589
- Sponsor's protocol ID
- ABI for tinnitus
- Status last verified
- Feb 2024
- First submitted
- 3 Dec 2015
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31201186
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
- ClinicalTrials.gov ID
- NCT02630589
- Acronym / sponsor ID
- ABI for tinnitus
- Conditions
- Tinnitus
- Keywords
- tinnitus, auditory brainstem implant, electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- MED-EL Elektromedizinische Geräte GmbH
- Study start
- Jul 2016
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: 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.
Objective. To evaluate the efficacy of an ABI for the suppression of unilateral, intractable tinnitus and to establish the safety of the ABI for this new indication.
Study design. This is a single center, non-randomized, prospective cohort, intervention pilot study. There is no control group. In this study, 10 patients will be implanted with an ABI.
Study population. Adult patients with invalidating, unilateral, intractable tinnitus and ipsilateral severe hearing loss are included in this study. All study participants have no significant comorbidity and are mentally competent.
Intervention. All study participants receive an ABI, which will be neurosurgically implanted. The ABI will be switched on 6 weeks after implantation. The surgery and post-surgery follow-up and switch-on procedures are consistent with the intended use of the ABI.
Main study parameters. The primary outcome is change in the Tinnitus Functioning Index (TFI). The endpoint is set at 1 year after implantation. Follow up will take place until 5 years after implantation.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness. The implantation, activation and fitting of the ABI will be performed exactly as described in the existing protocols for intended use, however in this study, the ABI is placed for another indication. Implantation of the ABI requires hospital admission for estimated 4 days. After dismissal, patients visit the outpatient clinic at least 8 times in the first year, depending on the amount of fitting session necessary. Implantation of the ABI is an invasive procedure, which potentially can cause severe complications (meningitis 3,8%, transient hydrocephalus 1,3%, cerebellar contusion 1,2%). Other complication that may occur are infection, bleeding, hearing loss and other cranial nerve dysfunctions. By an extensive training program for the neurosurgeon and presence of the experienced surgeon during the first surgical procedures, the investigators feel that neurosurgical risks and risk of device failure due to inadequate implantation can be limited. In this pilot study, the effects on hearing and tinnitus are still uncertain, however based on the results published in literature the investigators are confident that the effects on both will be positive. Nonauditory side-effects and disappointing results on hearing and/or tinnitus can be well managed by altering stimulation strategy or if necessary, by turning off the device. Tinnitus can be severely invalidating with a large impact on quality of life and the ABI is promising in reducing tinnitus in these patients. This study imposes a significant risk on the study participants. However, the investigators feel that the risks outweighs the potential to ameliorate severely debilitating tinnitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABI implantation | Experimental | Device: Auditory brainstem implantAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auditory brainstem implantAlso: ABIThe 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. | Device | ABI implantation |
Primary outcome
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
7 secondary outcomes
Pure tone audiometry
Time frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Tinnitus Handicap Inventory (THI)
Time frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Vestibular test
Time frame: pre-op, 3 months postoperative
Visual Analogue Score (VAS)
Time frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Hospital anxiety and depression scale (HADS)
Time frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
Tinnitus analysis
Time frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 31201186van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory brainstem implant in people with Tinnitus, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Functioning Index (TFI) (time frame: pre-op, 3 months, 6 months, 1, 2,3,4,5 year postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.