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The role of the flocculus in tinnitus.

A prospective study on the role of the cerebellar flocculus in tinnitus: the effect of surgical manipulation and tumor presence and the relation with electrophysiological and infection parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26264
Enrollment
100
Registered
2019-04-06
Start date
2019-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Interventions

None listed

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. Part 2: To objectify the relation between tinnitus and flocculus activity, quantified by direct response measurements on the flocculus. 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

MeasureTime frame
Part 1: 1. Relation between flocculus function and tinnitus presence and severity. 2. Relation between CPA tumor volume and tinnitus 3. Relation between flocculus volume and fossa posterior volume 4. Differences in flocculus function before and after treatment 5. Differences in tinnitus severity before and after treatment 6. Related between tinnitus and hearing thresholds? 7. Relation between tinnitus severity and quality of life (EQ-5D) Part 2: 1. Relation between floccular activity and flocculus function before flocculus manipulation

Contacts

Public ContactLilian Mennink

Universitair Medisch Centrum Groningen

l.m.mennink@umcg.nl050 361 28 37

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)