Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05529745 |
| Other study ID # |
EK-BR-158/20-1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2023 |
| Est. completion date |
May 31, 2027 |
Study information
| Verified date |
August 2022 |
| Source |
Klinik Bavaria |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Depending on their localization, cerebellar lesions cause various pronounced cognitive and/or
affective dysfunctions, which are causally related to the involvement of cerebellar
structures in neuronal networks for higher-order processing of cognitive and emotional items
in the association areas of the cerebral cortex. For further investigation, event-related
potential (ERP) analyses will be performed to record and visualize specific signals in the
surface EEG, which should provide information about the course of treatment of
neurorehabilitation with respect to a close correlation and thus predictive power to
functional recovery that occurred as a result of cerebellar injury. With EEG parameters and
clinical examination findings including neuropsychology, the functions for four thematically
distributed domains (affective: prosody; cognitive: abstraction, linguistic and formal
incongruence) will be recorded and evaluated over a four-week structured neurorehabilitation
with an average therapy volume.
Description:
Cerebellar damage causes various cognitive and affective dysfunctions to varying degrees
depending on its location, with cognitive abnormalities seen primarily in the posterior
lobes, whereas disorders of affect modulation are seen more frequently in lesions of the
vermis. Causally, cerebellar structures are thought to be involved in neuronal networks
distributed primarily within temporal, parietal, and frontal association cortices for
higher-order processing of cognitive and emotional items. Based on the evidence to date,
cerebellar areas appear to be involved at the level of congruent and incongruent associations
with different temporal binding of the cerebral networks responsible for them. For further
investigation, event-related potential (ERP) analyses will be performed to capture and
represent temporal signal dynamics in surface EEG, which will be used to calculate predictive
values for the quality and extent of neurorehabilitation applications for functional recovery
and thus clinical outcome via neurophysiological markers. In addition to clinical scales and
neuropsychological investigations, the processing of four thematically distributed (prosody,
abstraction, linguistic and formal incongruence) trials at the beginning and after about four
weeks of a structured neurorehabilitation with a therapy volume of at least 20 hours per week
of physical and occupational therapy as well as computer-assisted exercises, in their
temporal and topographical characteristics of neurophysiologically tangible functional
disorders and their dynamics in the course of treatment will be investigated via the
derivation of ERP.
