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NCT05813353 Clinical Trial

Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

Cognitive Impairment Clinical Trial

Official title:
Usability Study of the BAMCOG Followed by Concurrent Validation of the BAMCOG With the MoCA as a Monitoring Instrument for Perioperative Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05813353
Other study ID # nWMO-2020.106
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 14, 2021
Est. completion date December 31, 2022

Study information
Verified date April 2023
Source Catharina Ziekenhuis Eindhoven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose: 1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) 2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener 3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - > 65 years old - Scheduled for TAVI surgery - Able to play games on a tablet - For usability part > MoCA score of 26 or higher - Near native dutch speaker Exclusion Criteria: - Mental disorder (unable to play games) - Alcohol abuse (women <15 and men >22 alcoholic drinks/week) - No informed consent - Atrial fibrillitation (for ultrasound doppler)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Catharina Hospital Eindhoven

Sponsors (1)
Lead Sponsor Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Usability of BAMCOG 3 months preoperative
Primary Concurrent validation of BAMCOG with MoCA 3 months preoperative - 3 months postoperative
Primary Cerebral perfusion/carotid flow measurements Peroperative
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