Cognitive and Emotional Impairment After Stroke

NCT ID: NCT00506818

Last Updated: 2009-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-06-30

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.

Conditions

Stroke; Cognitive Impairment; Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

2

Intensive risk factor intervention

Group Type: ACTIVE_COMPARATOR

Multifactorial vascular-risk-factor-intervention

Intervention Type: OTHER

Interventions

Multifactorial vascular-risk-factor-intervention

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: collaborator

Sykehuset Asker og Baerum

OTHER

Sponsor Role: lead

Principal Investigators

Hege Ihle-Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Sykehuset Asker og Baerum

Locations

Sykehuset Asker og Baerum HF

Pb 83, 1309, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 32384876 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28583116 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26089677 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23957255 (View on PubMed)

Other Identifiers

1.2006.2076(REK)

Identifier Type: -

Identifier Source: secondary_id

16307(NSD)

Identifier Type: -

Identifier Source: secondary_id

1.2006.2076(REK)

Identifier Type: -

Identifier Source: org_study_id