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临床试验/NCT05529745
NCT05529745尚未招募不适用

Neurorehabilitation Impact on Neurocognitive Impairments in Cerebellar Lesions

Klinik Bavaria0 个研究点目标入组 50 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Changes of attentional and executive functioning in active group.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

  • any kind of history in neurological or psychiatric disorders

结局指标

主要结局

Changes of attentional and executive functioning in active group.

时间窗: 26 weeks

Beneficial changes in attentional and executive function performance in ischemic cerebellar injury after structured neurorehabilitation modules. Measurements will be succeed by the Cerebellar Cognitive Affective/ Schmahmann Syndrome Scale (German version) with a maximum of 120 of 120 points, i.e. an increase of the test performance with higher point values along the neurorehabilitation procedure is considered as an indication of clinical improvement.

次要结局

  • Extension of daily activities and life quality.(52 weeks)

研究者

发起方
Klinik Bavaria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Adamaszek

Michael Adamaszek, head of Dept. Clinical and Cognitive Neurorehabilitation

Klinik Bavaria

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