A prospective study on the role of the cerebellar (para)flocculus in tinnitus: the relation with electrophysiological parameters and inflammatory mediators

A prospective study on the role of the cerebellar (para)flocculus in tinnitus: the relation with electrophysiological parameters and inflammatory mediators - The role of the flocculus in tinnitus

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55531

Enrollment

Registered

2019-05-20

Start date

2020-08-04

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

hearing of sound when no external sound is present Tinnitus

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Adult, aged 18 years or older; - Undergoing microvascular decompression for hemifacial spasms or retrosigmoid removal of a CPA tumor. - Agrees to participate in the obligatory measurements 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

Exclusion criteria

Exclusion criteria: - Suffering from bilateral CPA tumors - Former surgery at the ipsi- or contralateral CPA region. - Radiotherapy at the ipsi- or contralateral CPA region prior to surgery. - Contralateral or bilateral complete deafness. - Presence of pulsatile tinnitus synced with the heartbeat. A potential subject who meets the following additional criterium will be excluded from participation in module 2 of this study: - Presence of a (chronic) inflammatory disease.

Design outcomes

Primary

Measure	Time frame
In module 1, we intend to objectify the relation between tinnitus, flocculus function and flocculus activity, quantified by direct response measurements on the flocculus. In module 2, we intend to examine the relation between tinnitus and inflammation, quantified by expression of anti-glial fibrillary acidic protein (GFAP) as a marker of astrocytes, anti-CD11b (OX-42) as a marker for microglia like cells and cytokine levels in a choroid plexus biopsy, cytokine levels in serum and liquor and serum inflammation levels.	—

Measure

Time frame

In module 1, we intend to objectify the relation between tinnitus, flocculus function and flocculus activity, quantified by direct response measurements on the flocculus. In module 2, we intend to examine the relation between tinnitus and inflammation, quantified by expression of anti-glial fibrillary acidic protein (GFAP) as a marker of astrocytes, anti-CD11b (OX-42) as a marker for microglia like cells and cytokine levels in a choroid plexus biopsy, cytokine levels in serum and liquor and serum inflammation levels.

—

Secondary

Measure	Time frame
1. Relation between flocculus function and tinnitus presence and severity. 2. Relation between tinnitus and hearing thresholds 3. Relation between tinnitus severity and quality of life (EQ-5D)	—

Countries

Netherlands

Outcome results