Cognitive and Emotional Impairment After Stroke

Stroke Clinical Trial

Official title:

Cognitive and Emotional Impairment After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00506818
• Other study ID #: 1.2006.2076(REK)
• Secondary ID: 1.2006.2076(REK)
• Status: Completed
• Phase: N/A
• First received: July 23, 2007
• Last updated: September 18, 2009
• Start date: February 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2009
• Source: Sykehuset Asker og Baerum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment
• Dementia, Vascular
• Stroke
• Vascular Dementia

Intervention

Other:
• Multifactorial vascular-risk-factor-intervention

Locations

Country	Name	City	State
Norway	Sykehuset Asker og Baerum HF	Pb 83	1309

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Asker og Baerum	University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD		8-12 months after stroke onset
Secondary	Prevalence of dementia and depression after stroke		8-12 month after stroke onset