Cognitive and Emotional Impairment After Stroke
Primary Purpose
Stroke, Cognitive Impairment, Vascular Dementia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Multifactorial vascular-risk-factor-intervention
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring emotional symptoms, vascular risk-factors
Eligibility 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
Sites / Locations
- Sykehuset Asker og Baerum HF
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
2
Arm Description
Intensive risk factor intervention
Outcomes
Primary Outcome Measures
Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD
Secondary Outcome Measures
Prevalence of dementia and depression after stroke
Full Information
NCT ID
NCT00506818
First Posted
July 23, 2007
Last Updated
September 18, 2009
Sponsor
Sykehuset Asker og Baerum
Collaborators
University of Oslo
1. Study Identification
Unique Protocol Identification Number
NCT00506818
Brief Title
Cognitive and Emotional Impairment After Stroke
Official Title
Cognitive and Emotional Impairment After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sykehuset Asker og Baerum
Collaborators
University of Oslo
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cognitive Impairment, Vascular Dementia
Keywords
emotional symptoms, vascular risk-factors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intensive risk factor intervention
Intervention Type
Other
Intervention Name(s)
Multifactorial vascular-risk-factor-intervention
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Prevalence of dementia and depression after stroke
Time Frame
8-12 month after stroke onset
10. Eligibility
Sex
All
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hege Ihle-Hansen, MD
Organizational Affiliation
Sykehuset Asker og Baerum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Asker og Baerum HF
City
Pb 83
State/Province
1309
ZIP/Postal Code
RUD
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
32384876
Citation
Hagberg G, Ihle-Hansen H, Fure B, Thommessen B, Ihle-Hansen H, Oksengard AR, Beyer MK, Wyller TB, Muller EG, Pendlebury ST, Selnes P. No evidence for amyloid pathology as a key mediator of neurodegeneration post-stroke - a seven-year follow-up study. BMC Neurol. 2020 May 8;20(1):174. doi: 10.1186/s12883-020-01753-w.
Results Reference
derived
PubMed Identifier
28583116
Citation
Ihle-Hansen H, Hagberg G, Fure B, Thommessen B, Fagerland MW, Oksengard AR, Engedal K, Selnes P. Association between total-Tau and brain atrophy one year after first-ever stroke. BMC Neurol. 2017 Jun 5;17(1):107. doi: 10.1186/s12883-017-0890-6.
Results Reference
derived
PubMed Identifier
26089677
Citation
Ihle-Hansen H, Thommessen B, Fagerland MW, Oksengard AR, Wyller TB, Engedal K, Fure B. Blood pressure control to prevent decline in cognition after stroke. Vasc Health Risk Manag. 2015 Jun 9;11:311-6. doi: 10.2147/VHRM.S82839. eCollection 2015.
Results Reference
derived
PubMed Identifier
23957255
Citation
Ihle-Hansen H, Thommessen B, Fagerland MW, Oksengard AR, Wyller TB, Engedal K, Fure B. Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. Aging Ment Health. 2014 Jul;18(5):540-6. doi: 10.1080/13607863.2013.824406. Epub 2013 Aug 20.
Results Reference
derived
Learn more about this trial
Cognitive and Emotional Impairment After Stroke
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