Cognitive and Emotional Impairment After Stroke

• Sponsor: Sykehuset Asker og Baerum (Other)
• Overall Status: Completed
• CT.gov ID: NCT00506818
• Collaborator: University of Oslo (Other)
• Enrollment: 250
• Location: 1
• Arm: 1
• Duration (Months): 28
• Patients Per Site Per Month: 8.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Cognitive Impairment; Vascular Dementia	Other: Multifactorial vascular-risk-factor-intervention	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Prevention
• Official Title: Cognitive and Emotional Impairment After Stroke
• Study Start Date: Feb 1, 2007
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2 Intensive risk factor intervention	Other: Multifactorial vascular-risk-factor-intervention

Outcome Measures

Primary Outcome Measures

1. Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD [8-12 months after stroke onset]

Secondary Outcome Measures

1. Prevalence of dementia and depression after stroke [8-12 month after stroke onset]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sykehuset Asker og Baerum HF	Pb 83	1309	Norway	RUD

Sponsors and Collaborators

• Sykehuset Asker og Baerum
• University of Oslo

Investigators

• Principal Investigator: Hege Ihle-Hansen, MD, Sykehuset Asker og Baerum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00506818
• Other Study ID Numbers: 1.2006.2076(REK); 1.2006.2076(REK); 16307(NSD)
• First Posted: Jul 25, 2007
• Last Update Posted: Sep 21, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: emotional symptoms; vascular risk-factors
• Additional relevant MeSH terms: Stroke; Dementia, Vascular

Study Results

No Results Posted as of Sep 21, 2009