Neurorehabilitation Impact on Neurocognitive Impairments in Cerebellar Lesions

NCT05529745 | Not Yet Recruiting

• 1 other identifier: EK-BR-158/20-1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebellum; Injury

Keywords

Cerebellum - cognitive functions - neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes of attentional and executive functioning in active group.

  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.

  26 weeks

Secondary Outcomes (1)

• Extension of daily activities and life quality.

  52 weeks

Study Arms (2)

Treatment in cerebellar lesioned patient

EXPERIMENTAL

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

Other: Neurorehabilitation cerebellar cognitive disorder

Treatment in supratentorial lesioned patient

ACTIVE COMPARATOR

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

Other: Neurorehabilitation cerebellar cognitive disorder

Interventions

Neurorehabilitation cerebellar cognitive disorder 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 cerebellar lesioned patient; Treatment in supratentorial lesioned patient

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• any kind of history in neurological or psychiatric disorders

Sponsors & Collaborators

• Klinik Bavaria: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michael Adamaszek, head of Dept. Clinical and Cognitive Neurorehabilitation

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 7, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: September 7, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share