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Cognitive and Emotional Impairment After Stroke

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ClinicalTrials.gov Identifier: NCT00506818
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : September 21, 2009
Sponsor:
Collaborator:
Information provided by:

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
Stroke Cognitive Impairment Vascular Dementia Other: Multifactorial vascular-risk-factor-intervention

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

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 [ Time Frame: 8-12 months after stroke onset ]

Secondary Outcome Measures :
  1. Prevalence of dementia and depression after stroke [ Time Frame: 8-12 month after stroke onset ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506818


Locations
Norway
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00506818     History of Changes
Other Study ID Numbers: 1.2006.2076(REK)
16307(NSD)
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: September 21, 2009
Last Verified: September 2009

Keywords provided by Sykehuset Asker og Baerum:
emotional symptoms
vascular risk-factors

Additional relevant MeSH terms:
Stroke
Dementia
Cognitive Dysfunction
Dementia, Vascular
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases