Last updated: February 9, 2024
Sponsor: Maastricht University Medical Center
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Tinnitus
Treatment
Deep Brain Stimulation
Clinical Study ID
NCT03976908
NL67027.068.18
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Medically refractory tinnitus. Patient does not respond to available tinnitustreatments (hearing aids, cognitive treatments) and is thoroughly evaluated by themultidisciplinary tinnitus team in MUMC. Thus patients do not respond to both of thefollowing 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 similarversion 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
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 asbipolar disorder, dementia, addiction, personality disorders); diagnosed by apsychiatrist. A psychiatrist will screen the patients for this matter.
- Depression or anxiety disorder which was already present before tinnitus. Apsychiatrist 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
Study Design
Total Participants: 6
Treatment Group(s): 1
Primary Treatment: Deep Brain Stimulation
Phase:
Study Start date:
January 06, 2021
Estimated Completion Date:
January 31, 2025
Connect with a study center
MUMC+
Maastricht, 6229HX
NetherlandsSite Not Available
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