ringing of the ears Tinnitus
Conditions
Interventions
Subjects will receive bilateral DBS electrodes, radiologically and
electrophysiologically guided in the MGB of the thalamus, following a standard
surgical procedure.
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is tinnitus severity, identified by means of a questionnaire, the Tinnitus Function Index (TFI), which is validated in Dutch. The TFI will be measured on a regular basis depending on the stage the study is in. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - Tinnitus loudness and burden, both identified by means of Visual Analogue Scales (VAS). The VAS will be measured regularly. - Neuropsychological outcome: cognitive functioning (test battery), quality of life (36-Item Short Form Health Survey; SF-36), depression and anxiety (Beck Depression Inventory II; BDI-II, Beck Anxiety Inventory; BAI) - Audiological evaluation: pure-tone and speech audiometry, auditory brainstem responses (ABR). - Electrophysiological measurements: EEG, local field potentials. | — |
Countries
Netherlands
Outcome results
None listed