Neurorehabilitation Impact on Neurocognitive Impairments in Cerebellar Lesions

NCT ID: NCT05529745

Last Updated: 2022-09-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2027-05-31

Brief 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.

Detailed 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.

Conditions

Cerebellum; Injury

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment in cerebellar lesioned patient

Group of patients with a lesion of the cerebellum gaining a neurorehabilitation intervention

Group Type: EXPERIMENTAL

Neurorehabilitation cerebellar cognitive disorder

Intervention Type: OTHER

Influence of neurorehabilitation treatment lines of physiotherapy and exercise therapy including scheduled occupational therapy to adapt and improve cognitive-affective disorders in cerebellar lesions.

Treatment in supratentorial lesioned patient

Group of patients with a lesion of the supratentorial area gaining a neurorehabilitation intervention

Group Type: ACTIVE_COMPARATOR

Neurorehabilitation cerebellar cognitive disorder

Intervention Type: OTHER

Influence of neurorehabilitation treatment lines of physiotherapy and exercise therapy including scheduled occupational therapy to adapt and improve cognitive-affective disorders in cerebellar lesions.

Interventions

Neurorehabilitation cerebellar cognitive disorder

Influence of neurorehabilitation treatment lines of physiotherapy and exercise therapy including scheduled occupational therapy to adapt and improve cognitive-affective disorders in cerebellar lesions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• active group: patients with a cerebrovascular lesion within the cerebellum
• comparator group: patients with a cerebrovascular lesion supratentorial

Exclusion Criteria

• any kind of history in neurological or psychiatric disorders

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Klinik Bavaria

OTHER

Sponsor Role: lead

Responsible Party

Michael Adamaszek

Michael Adamaszek, head of Dept. Clinical and Cognitive Neurorehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EK-BR-158/20-1

Identifier Type: -

Identifier Source: org_study_id