Cognitive and Emotional Impairment After Stroke

Not Applicable

Completed

• Conditions: Stroke; Cognitive Impairment; Vascular Dementia
• Interventions: Other: Multifactorial vascular-risk-factor-intervention

• Registration Number: NCT00506818
• Lead Sponsor: Sykehuset Asker og Baerum

Brief Summary

Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-07-23
• Study First Submitted QC: 2007-07-23
• Study First Posted: 2007-07-25
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• First ever stroke or TIA
• No cognitive decline (IQCODE < 3,7)
• Survived the acute stroke
• Expected to live at least for one year after stroke

Exclusion Criteria

• Cognitive decline

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Multifactorial vascular-risk-factor-intervention	Intensive risk factor intervention

Primary Outcome Measures

Name	Time	Method
Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD	8-12 months after stroke onset

Secondary Outcome Measures

Name	Time	Method
Prevalence of dementia and depression after stroke	8-12 month after stroke onset

Trial Locations

Locations (1)

Sykehuset Asker og Baerum HF; 🇳🇴 Pb 83, 1309, Norway