Cognitive and Emotional Impairment After Stroke

This study has been completed.
Sponsor:
Collaborator:
University of Oslo
Information provided by:
Sykehuset Asker og Baerum
ClinicalTrials.gov Identifier:
NCT00506818
First received: July 23, 2007
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Cognitive and Emotional Impairment After Stroke

Resource links provided by NLM:


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: 250
Study Start Date: February 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Intensive risk factor intervention
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Sykehuset Asker og Baerum

Additional 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), 1.2006.2076(REK), 16307(NSD)
Study First Received: July 23, 2007
Last Updated: September 18, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

Additional relevant MeSH terms:
Cerebral Infarction
Cognition Disorders
Dementia, Vascular
Stroke
Arterial Occlusive Diseases
Arteriosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Intracranial Arterial Diseases
Intracranial Arteriosclerosis
Leukoencephalopathies
Mental Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014