Clinical trial NCT01953068: Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
Official title: Executive Reaction Time Test in Assessment of Cognitive Dysfunction After Aortic Valve Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurobehavioral Manifestations
Keywords: POCD
Executive Reaction Time Test
Aortic valve surgery
Cognitive functions
Transcatheter Aortic Valve Implantation
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elective aortic valve replacement (AVR) and transcatheter aortic valve implantation (TAVI) patients at Tampere University Hospital Heart Center

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Executive Reaction Time Test response speed
timeFrame: 6 months
Secondary outcomes:
measure: Executive Reaction Time Test: error% of answers
timeFrame: 6 months
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital Heart Center
state: Pirkanmaa
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Jonne Liimatainen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Behavioral Neurology Research Unit, Pirkanmaa Hospital District
name: Kaisa Hartikainen, Professor
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, Professor
role: STUDY_DIRECTOR
affiliation: Tampere University Hospital Heart Center
name: Kati Järvelä, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liimatainen J, Perakyla J, Jarvela K, Sisto T, Yli-Hankala A, Hartikainen KM. Improved cognitive flexibility after aortic valve replacement surgery. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):630-6. doi: 10.1093/icvts/ivw170. Epub 2016 May 30.