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PRediction Of Cognitive Recovery After Stroke: a role for new MRI modalities in daily clinical practice?

PRediction Of Cognitive Recovery After Stroke: a role for new MRI modalities in daily clinical practice? - PROCRAS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46000
Enrollment
350
Registered
2016-04-18
Start date
2016-07-06
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cerebrovascular accident Stroke

Interventions

None listed

Sponsors

Sint Elisabeth Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: For cognitive impaired group: Ischemic stroke (clinical diagnosis, CT-scan confirmed or not) Age 50 years or older Montreal Cognitive Assessment (MoCa) score

Exclusion criteria

Exclusion criteria: -Pre-existent dementia (clinical diagnosis) and/or Pre-existing cognitive impairment (score of 3.6 or higher on the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)) -Life expectancy

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study is recovery of cognitive function in the first year after stroke, measured with a 60 minute neuropsychological assessment battery For the primary analyses cognitive recovery is operationalized as a transition from a mild vascular cognitive disorder in the acute stage to no disorder after one year or a transition from a major vascular disorder in the acute stage to a mild or no vascular cognitive disorder after one year.

Secondary

MeasureTime frame
The secondary cognitive outcome measure is deterioration of cognitive function, operationalized as transition from mild to major vascular cognitive disorder, or a transition from no disorder in the acute stage to a mild or major vascular cognitive disorder after one year. Additional outcome measures that will be collected include also important outcome parameters as Cognitive complaints (CLCE-24), self-efficacy (Self Efficacy for symptom management scale (SEsx)), Quality of Life measured by the Stroke-Specific Quality of Life Scale (SS-QOL), emotional functioning (Hospital Anxiety and Depression Scale (HADS), neuropsychiatric inventory-questionnaire (NPI-Q)) and participation measured by Utrecht Scale for Evaluation of Rehabilitation-Participation (User-P) and Patient Reported Outcomes Measurement System (PROMIS-10) will be assessed at one year post stroke.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)