Cerebellum; InjuryNRCEcogNCT05529745
Neurorehabilitation Impact on Neurocognitive Impairments in Cerebellar Lesions
A study testing Neurorehabilitation cerebellar cognitive disorder in people with Cerebellum; Injury, run by Klinik Bavaria.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebellum; Injury
- What is being tested?
- Neurorehabilitation cerebellar cognitive disorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- active group: patients with a cerebrovascular lesion within the cerebellum
- comparator group: patients with a cerebrovascular lesion supratentorial
Who cannot join
- any kind of history in neurological or psychiatric disorders
About this study
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.
Read the 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
- Being tested
- Neurorehabilitation cerebellar cognitive disorder
- Keywords
- Cerebellum - cognitive functions - neurorehabilitation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurorehabilitation cerebellar cognitive disorderOther
Influence of neurorehabilitation treatment lines of physiotherapy and exercise therapy including scheduled occupational therapy to adapt and improve cognitive-affective disorders in cerebellar lesions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment in cerebellar lesioned patient | Experimental | Group of patients with a lesion of the cerebellum gaining a neurorehabilitation intervention Receives: 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 Receives: Other: Neurorehabilitation cerebellar cognitive disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (1)
Extension of daily activities and life quality.
Growing action behavior (recorded by SF-36 scale) in everyday life, whereby an increase from low point values up to high point values (between a range of 0 points with very low quality of life as minimum, and up to 100 points as a maximum of quality of life) indicates a growing quality of life due to neurologic impromenet .
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jun 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellum; InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinik Bavaria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Adamaszek, Klinik Bavaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529745
- Sponsor's protocol ID
- EK-BR-158/20-1
- Acronym
- NRCEcog
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurorehabilitation Impact on Neurocognitive Impairments in Cerebellar Lesions
- ClinicalTrials.gov ID
- NCT05529745
- Acronym / sponsor ID
- NRCEcog / EK-BR-158/20-1
- Conditions
- Cerebellum; Injury
- Keywords
- Cerebellum - cognitive functions - neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Klinik BavariaUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment in cerebellar lesioned patient | Experimental | Other: Neurorehabilitation cerebellar cognitive disorderGroup of patients with a lesion of the cerebellum gaining a neurorehabilitation intervention |
| Treatment in supratentorial lesioned patient | Active comparator | Other: Neurorehabilitation cerebellar cognitive disorderGroup of patients with a lesion of the supratentorial area gaining a neurorehabilitation intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- active group: patients with a cerebrovascular lesion within the cerebellum
- comparator group: patients with a cerebrovascular lesion supratentorial
Key exclusion criteria (1 listed)
- any kind of history in neurological or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurorehabilitation cerebellar cognitive disorderInfluence of neurorehabilitation treatment lines of physiotherapy and exercise therapy including scheduled occupational therapy to adapt and improve cognitive-affective disorders in cerebellar lesions. | Other | Treatment in cerebellar lesioned patient, Treatment in supratentorial lesioned patient |
Primary outcome
Changes of attentional and executive functioning in active group.
Time frame: 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.
1 secondary outcome
Extension of daily activities and life quality.
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Neurorehabilitation cerebellar cognitive disorder in people with Cerebellum; Injury, run by Klinik Bavaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of attentional and executive functioning in active group. (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2022.