Deep Brain Stimulation for Tinnitus
Tinnitus
About this trial
This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- Medically refractory tinnitus. Patient does not respond to available tinnitus treatments (hearing aids, cognitive treatments) and is thoroughly evaluated by the multidisciplinary tinnitus team in MUMC. Thus patients do not respond to both of the following treatments (i.e. TQ is still ≥ 47):
- Hearing aids (except if hearing is normal)
- 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:
- Not pulsatile
- Unilateral or bilateral
- Severe tinnitus (based on the TQ score ≥ 47)
- 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. A psychiatrist will screen the patients for this matter.
- Depression or anxiety disorder which was already present before tinnitus. A psychiatrist will screen the patients for this matter.
- 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 implantable electronic devices that potentially could interfere with DBS, e.g. cochlear implants, auditory brainstem implants or cortical implants
Sites / Locations
- MUMC+Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
ON-OFF
OFF-ON
Patients receive the same baseline, a 6 week period of stimulation ON (masked for both patient and investigator), one week of washout, a 6 week period of stimulation OFF (masked for both patient and investigator), one week of washout, a 6 month follow-up period of open-label stimulation ON.
Patients receive the same baseline, a 6 week period of stimulation OFF (masked for both patient and investigator), one week of washout, a 6 week period of stimulation ON (masked for both patient and investigator), one week of washout, a 6 month follow-up period of open-label stimulation ON.