Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures

Neurobehavioral Manifestations Clinical Trial

Official title:

Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953068
• Other study ID #: R13043
• Status: Completed
• Start date: January 2014
• Est. completion date: May 2016

Study information

• Verified date: April 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Up to 50% of patients undergoing surgical aortic valve operation suffer from some level of post-operative cognitive dysfunction (POCD). Frontal lobes of the brain, where executive functions are located, are highly susceptible to trauma caused by possible blood malperfusion to these areas of the brain during surgery. Conventional and established neuropsychological test methods are poor in distinguishing these kinds of trauma, as they are isolated, structured tests that do not require multitasking and processing of multiple stimuli at the same time.

The phase 1 goal of this study is to employ an experimental Executive reaction time (RT) test to see if this method could improve objective detection of subtle brain dysfunction assumed to underlie persistent cognitive, somatic, and affective complaints reported by patients who have undergone electic aortic valve replacement (AVR) surgery. Phase 2 of the study will concentrate on patients undergoing transcatheter aortic valve implantation (TAVI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• undergoing elective aortic valve stenosis surgery (phase 1) or transcatheter aortic valve implantation (phase 2)

Exclusion Criteria:

• Previous neurological or psychiatric disorder.

• Significant visual problem

• Problems with upper arm/hand use

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Neurobehavioral Manifestations

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere
Finland	Tampere University Hospital Heart Center	Tampere	Pirkanmaa

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Executive Reaction Time Test response speed		6 months
Secondary	Executive Reaction Time Test: error% of answers		6 months