Cognitive ImpairmentNCT05813353
Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements
An observational study of Cognitive Impairment and Older People--Abuse of, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment, Older People--Abuse of, Aortic Stenosis, Severe
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Jul 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing TAVI surgery
Who may be able to join
- > 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
Who cannot join
- Mental disorder (unable to play games)
- Alcohol abuse (women <15 and men >22 alcoholic drinks/week)
- No informed consent
- Atrial fibrillitation (for ultrasound doppler)
Trial locations and contacts
1 site in 1 country.
About this study
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
Purpose:
- Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning)
- Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener
- Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements
- Medical subject headings
- Cognitive Dysfunction, Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of BAMCOG
Measured: 3 months preoperative
Concurrent validation of BAMCOG with MoCA
Measured: 3 months preoperative - 3 months postoperative
Cerebral perfusion/carotid flow measurements
Measured: Peroperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start14 Jul 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariska te Pas, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813353
- Sponsor's protocol ID
- nWMO-2020.106
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05813353
- Acronym / sponsor ID
- nWMO-2020.106
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
- Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning)
- Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener
- Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing TAVI surgery
Key inclusion criteria (5 listed)
- > 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
Key exclusion criteria (4 listed)
- Mental disorder (unable to play games)
- Alcohol abuse (women <15 and men >22 alcoholic drinks/week)
- No informed consent
- Atrial fibrillitation (for ultrasound doppler)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Usability of BAMCOG
Time frame: 3 months preoperative
Concurrent validation of BAMCOG with MoCA
Time frame: 3 months preoperative - 3 months postoperative
Cerebral perfusion/carotid flow measurements
Time frame: Peroperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Older People--Abuse of, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of BAMCOG (time frame: 3 months preoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.