Clinical trial NCT00506818: Cognitive and Emotional Impairment After Stroke
Official title: Cognitive and Emotional Impairment After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Cognitive Impairment
Vascular Dementia
Keywords: emotional symptoms
vascular risk-factors
Lead sponsor: Sykehuset Asker og Baerum
Sponsor class: OTHER
Collaborators: name: University of Oslo
First posted: 2007-07-25
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD
timeFrame: 8-12 months after stroke onset
Secondary outcomes:
measure: Prevalence of dementia and depression after stroke
timeFrame: 8-12 month after stroke onset
Other outcomes:
Locations:
city: Pb 83
country: Norway
facility: Sykehuset Asker og Baerum HF
state: 1309
Study officials:
affiliation: Sykehuset Asker og Baerum
name: Hege Ihle-Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.