Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Cognitive and Emotional Impairment After Stroke
This study is currently recruiting participants.
Verified by Sykehuset Asker og Baerum, February 2007
Sponsors and Collaborators: Sykehuset Asker og Baerum
University of Oslo
Information provided by: Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier: NCT00506818
  Purpose

Cognitive and emotional symptoms are often sees 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). We 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. We 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 Intervention
Stroke
Cognitive Impairment
Emotional Symptoms
Vascular Risk-Factors
Vascular Dementia
Other: Multifactorial vascular-risk-factor-intervention

MedlinePlus related topics: Dementia
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Parallel Assignment, Efficacy Study
Official Title: Cognitive and Emotional Impairment After Stroke

Further study details as provided by Sykehuset Asker og Baerum:

Primary Outcome Measures:
  • 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:
  • Prevalence of dementia and depression after stroke [ Time Frame: 8-12 month after stroke onset ]

Estimated Enrollment: 300
Study Start Date: February 2007
Estimated Study Completion Date: January 2010
Arms Assigned Interventions
2: No Intervention
Care as usual in the primary health care
Other: Multifactorial vascular-risk-factor-intervention

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506818

Contacts
Contact: Hege Ihle-Hansen, MD +47 67809400 hege.ihle-hansen@sabhf.no
Contact: Brynjar Fure, PhD +47 67809400 bryfure@online.no

Locations
Norway, 1309
Sykehuset Asker og Baerum HF Recruiting
Pb 83, 1309, Norway, RUD
Contact: Hege Ihle-Hansen, MD     +47 67809400     hege.ihle-hansen@sabhf.no    
Contact: Brynjar Fure, PhD     +47 67809400     bryfure@online.no    
Principal Investigator: Hege Ihle-Hansen, MD            
Sponsors and Collaborators
Sykehuset Asker og Baerum
University of Oslo
Investigators
Principal Investigator: Hege Ihle-Hansen, MD Sykehuset Asker og Baerum
  More Information

Study ID Numbers: 1.2006.2076(REK), 1.2006.2076(REK), 16307(NSD)
Study First Received: July 23, 2007
Last Updated: July 23, 2007
ClinicalTrials.gov Identifier: NCT00506818  
Health Authority: Norway: The National Committees for Research Ethics in Norway;   Norway: Norwegian Social Science Data Services

Study placed in the following topic categories:
Arterial Occlusive Diseases
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Cognition Disorders
Intracranial Arteriosclerosis
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Ischemia
Dementia, Vascular
Brain Infarction
Dementia
Infarction
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009