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.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
• Safety: changes in hearing as measured by pure tone audiometry (PTA) and
speech discrimination tests from baseline to follow up; changes in vestibular
function as measured by vestibular tests between baseline and 3 months after
initial stimulation with the ABI.
• Change in TFI from 12 months to 5 years of follow up (long term effect).
• Change in VAS (visual analogue scale)-scores (tinnitus loudness, tinnitus
annoyance) from baseline to follow up.
• Change in HADS-scores (Hospital Anxiety and Depression Scale) from baseline
to follow up.
• Change is THI-scores (Tinnitus Handicap Index) from baseline to follow up.
• Tinnitus matching from baseline to follow up.
Background 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.
Study 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.
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.
Study burden and risks
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, we
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 we 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, we feel that the risks outweighs the potential to
ameliorate severely debilitating tinnitus.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
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. 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 <=90 dB (mean over 1-2-4 kHz).
- Functional hearing in the contralateral ear with PTA thresholds <=35dB with a minimal Δ25dB compared to the other (ipsilateral) ear.
- Informed consent after extensive oral and written information about the surgery, complications and the uncertain effect of the ABI on tinnitus
- Acceptable overall physical condition as declared by an anesthesiologist
- No detectable cause for tinnitus that requires causal therapy (e.g. glomus tumor, otosclerosis, arterio-venous malformation) as investigated by medical and otological examination
Exclusion criteria
- 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 yr
- 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 which might prevent placement of the ABI Active Electrode Array
- If the individual is known to be intolerant of the materials used in the implant (medical grade silicone, platinum, iridium and parylene c)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55276.042.15 |