Deep brain stimulation for refractory tinnitus

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria, all by consideration of the multidisciplinary expert
group:, • Medically refractory tinnitus. Patient does not respond to available
tinnitus treatment and is thoroughly evaluated by the multidisciplinary
tinnitus team in MUMC. Available tinnitus treatments are hearing aids (except
if hearing is normal) and evidence-based cognitive treatment in Hoensbroek
(Cima et al., 2012) or a similar version of this treatment in the MUMC
• Minimum age 18 years, maximum age 69 years.
• Experiencing tinnitus which is:
o Not pulsatile
oUnilateral or bilateral
o Severe tinnitus (based on the TQ score >= 47)
o Chronic and stable (present > 2 years and stable > 1 year).
• Bilateral hearing of high tone Fletcher Index < 60 dB
• Willingness to participate in this study (informed consent)

Exclusion Criteria

• Anatomic cause of tinnitus (e.g. vestibular schwannoma, tumour, middle-ear
pathology)
• DSM-V psychiatric disorders, other than depression or anxiety disorder (such
as bipolar disorder, dementia, addiction, personality disorders); diagnosed by
a psychiatrist
• Depression or anxiety disorder which was already present before tinnitus
• Cognitive impairment (assessed with standard *cognitive functioning battery
test* questionnaires) or coping problems (CISS-21)
• Active ear diseases that needs further attention according to research team
• Pregnancy or breast-feeding
• Active suicide thoughts or attempts
• Underlying malignancies, whenever life expectancy is lower than 2 years
• Other exclusion criteria are the same as for the standard DBS operation in
clinical care: significant cerebral atrophy, multiple white matter lesions or
focal brain anomalies.
• Contra-indication for Magnetic Resonance Imaging (claustrophobia or implanted
metal objects such as cardiac pacemakers, intracardiac lines, implanted
medication pumps, implanted electrodes in the brain, other intracranial metal
objects with the exception of dental fillings).
• Also general contra-indications for surgery are considered as exclusion
criteria, e.g. coagulopathies, The specialist team can decide on clinical
grounds that a patient does or does not qualify for MGB-DBS treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main endpoint is tinnitus severity, identified by means of a questionnaire,<br /><br>the Tinnitus Function Index (TFI), which is validated in Dutch. The TFI will be<br /><br>measured on a regular basis depending on the stage the study is in.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Tinnitus loudness and burden, both identified by means of Visual Analogue<br /><br>Scales (VAS). The VAS will be measured regularly.<br /><br>- Neuropsychological outcome: cognitive functioning (test battery), quality of<br /><br>life (36-Item Short Form Health Survey; SF-36), depression and anxiety (Beck<br /><br>Depression Inventory II; BDI-II, Beck Anxiety Inventory; BAI)<br /><br>- Audiological evaluation: pure-tone and speech audiometry, auditory brainstem<br /><br>responses (ABR).<br /><br>- Electrophysiological measurements: EEG, local field potentials.</p><br>