The role of the flocculus in tinnitus.
- Conditions
- Tinnitus
- Registration Number
- NL-OMON26264
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Adult, aged 18 years or older;
-Undergoing microvascular decompression for hemifacial spasms or trigeminal neuralgia or treatment of a CPA tumor (translabyrinthine/retrosigmoid surgical removal or radiotherapy);
-Agree to participate in part 1 of this study
-Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, filling out questionnaires and undergoing tests.
-Patient has sufficient mastery of the Dutch language to fill out the questionnaires.
-Signed and dated informed consent document prior to any study-related procedures
Patients meeting the following criterium will be asked to participate in part 2 and/or part 3 as well:
-Undergoing retrosigmoid CPA tumor removal or the microvascular decompression for hemifacial spasms
A potential subject who meets any of the following criteria will be excluded from participation in this study:
-Suffering from bilateral CPA pathology (i.e. tumor or neurovascular conflict)
-Bilateral complete deafness.
-Presence of contra-indications for a MRI-scan.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1: To evaluate the influence of surgical flocculus manipulation and presence of a CPA tumor on flocculus function and its relation with tinnitus presence and severity. Flocculus function is objectified by flocculus volume on a MRI and vestibular and eye movement tests. Tinnitus severity is quantified by the Tinnitus Functional Index score (TFI), tinnitus pitch and tinnitus loudness. <br><br>Part 2: To objectify the relation between tinnitus and flocculus activity, quantified by direct response measurements on the flocculus.<br><br>Part 3: To examine the relation between tinnitus and inflammation, quantified by expression of anti-glial fibrillary acidic protein (GFAP) as a marker of astrocytes and anti-CD11b (OX-42) as a marker for microglia like cells in a choroid plexus biopsy and serum inflammation levels.
- Secondary Outcome Measures
Name Time Method Part 1:<br>1.Relation between flocculus function and tinnitus presence and severity.<br>2.Relation between CPA tumor volume and tinnitus<br>3.Relation between flocculus volume and fossa posterior volume<br>4.Differences in flocculus function before and after treatment<br>5.Differences in tinnitus severity before and after treatment<br>6.Related between tinnitus and hearing thresholds?<br>7.Relation between tinnitus severity and quality of life (EQ-5D)<br>Part 2:<br>1.Relation between floccular activity and flocculus function before flocculus manipulation