Cognitive DeclineNCT06245005
Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
An observational study of Cognitive Decline, run by Ohio State University at 1 site in United States.
Trial summary
Investigators will evaluate feasibility of using a custom 6-game Lumosity brain exercise experience in busy clinical areas to obtain a quick, quantitative measure of cognitive reserve (first gameplay performance [FGP]) in older patients presenting for major surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognitive Decline
- What is being tested?
- Brain exercise gameplay on a portable electronic device
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2023to 30 Jan 2026
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 60 years of age or older, capable and willing to consent and scheduled to undergo non-cardiac/non-neurological surgery with an expected hospital stay of at least 72 hours.
Who may be able to join
- 60 years of age or older
- Capable and willing to consent
- Non-cardiac/non-neurological surgery with an expected hospital stay of at least 72 hours
- Anticipated ASA physical status I-IV
- English speaking
- Willingness to use computer-based device
Who cannot join
- Severe visual or auditory deficits
- Illiterate
- Surgery or procedure within the previous 6 months requiring general anesthesia
- Active Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol, or drug abuse
- ASA physical status V, VI
- Planned postoperative ICU admission
- Preoperative benzodiazepine administration (i.e. Midazolam, Diazepam)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
Official title: Investigation of a Novel Quantitative Measure of Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Investigators will evaluate feasibility of using a custom 6-game Lumosity brain exercise experience in busy clinical areas to obtain a quick, quantitative measure of cognitive reserve (first gameplay performance [FGP]) in older patients presenting for major surgery. Participants in this feasibility trial will serve as a pilot population to estimate postoperative delirium incidence in patients willing and able to complete the brief, self-directed, brain exercise experience on a portable electronic device in various preoperative encounters, and will provide insight into which preoperative encounter (outpatient clinic or morning of surgery preoperative holding) may be more conducive to brief preoperative cognitive evaluations and interventions in future studies. First gameplay performance obtained during study procedures will be compared based upon postoperative delirium status (positive verse negative) to evaluate predictive value of the custom 6-game battery. This will guide future studies of FGP as a quick, quantitative measure of cognitive reserve in older surgical patients, with potentially more utility in preoperative patients than other assessments of cognitive function.
Read the detailed description
Potential study participants will be identified by researchers monitoring The Ohio State University Preoperative Assessment Clinic (OPAC) and operating room (OR) schedules. Eligible patients will be contacted over-the-phone regarding willingness to participate. Surgeons will be made aware when their patients have been approached over the phone and updated accordingly if the patient agrees to be enrolled in the study. If willing, patients will be met at either their preoperative assessment at OPAC or their day of surgery at Preoperative Holding. Patients will be screened at this encounter for inclusion and exclusion criteria.
Following the initial screening encounter, patients will be required to provide informed consent prior to any study activities or data collection. Once informed consent is signed by both the subject and researcher, the researcher will provide the patient with a portable electronic device (laptop) with access to Lumosity brain exercise software (Lumos Labs, San Francisco, California, USA) and instruct participants to complete as many of the provided 6 games as possible. These 6 games were identified specifically from preliminary data indicating their postoperative delirium predictive capacity. Gameplay completion and performance scores will be coded and stored on the Lumosity software. Personal health information will not be used on the research device.
At this visit, the researcher will also collect demographic information (age, sex, body max index (BMI), ethnicity, and educational level) and relevant comorbidities via the Charlson Comorbidity Index (CCI). The research device will be collected at the end of the patient's visit at OPAC or just prior to surgery when in preoperative holding.
All patients will undergo surgery as planned. Time under anesthesia and type of surgery will be collected. On the first day following surgery, patients will be assessed by research members for the presence of delirium using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) at 0800 ± 2 hours and 1700 ± 2 hours. This will be repeated every postoperative day until postoperative day 7 or discharge, whichever comes first. Additionally, medical notes from the day of surgery to discharge or post-operative day (POD) 7 (whichever comes first) will be assessed for delirium by a researcher using a validated medical chart-based delirium assessment (CHART-DEL). Patients will be asked to complete the Discharge Survey Prior to hospital discharge or over the phone after discharge. In addition, their length of stay in the hospital and discharge location will be collected.
- Conditions
- Cognitive Decline
- Being tested
- Brain exercise gameplay on a portable electronic device
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain exercise gameplay on a portable electronic deviceDevice
Feasibility is defined as a 70% completion rate for at least 3 of the six brain exercise games in study participants from which a 'first gameplay score' can be determined. Investigators will also assess level of satisfaction with the brain exercise intervention and barriers to playing in the busy preoperative clinical settings as evaluated by a patient-centered questionnaire (Discharge Survey).
| Study group | Role | What they receive |
|---|---|---|
| OPAC | Feasibility to conduct brain exercise gameplay on a portable electronic device at Ohio State Preoperative Assessment Clinic (OPAC) Receives: Device: Brain exercise gameplay on a portable electronic device | |
| PREOP | Feasibility to conduct brain exercise gameplay on a portable electronic device at The Wexner Medical Center Preoperative Holding Areas. Receives: Device: Brain exercise gameplay on a portable electronic device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Lumosity 6-game brain exercise completion
Determine if brain exercise gameplay on a portable electronic device is feasible in two different preoperative settings (The Ohio State Preoperative Assessment Clinic (OPAC) and The Wexner Medical Center Preoperative Holding Areas).
Measured: up to 30 minutes after participants start the first Lumosity game brain exercise
Secondary outcomes (1)
Incidence of Postoperative Delirium
To assess the incidence of Postoperative Delirium
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start20 Sep 2023
- Primary completion30 Sep 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Humeidan, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245005
- Sponsor's protocol ID
- 2022H0419
- Status last verified
- Feb 2026
- First submitted
- 18 Jan 2024
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The proportion (95% confidence interval) of patients successfully completing at least three games will be estimated overall and in each setting. Investigators will additionally summarize the total number of games played overall and in each setting. Questionnaire results will be summarized in each setting as absolute data with 0: strongly disagree, 25: disagree, 50: neutral, 75: agree, and 100: strongly agree.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Novel Quantitative Measure of Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06245005
- Acronym / sponsor ID
- 2022H0419
- Conditions
- Cognitive Decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 7 Feb 2024 (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.
Investigators will evaluate feasibility of using a custom 6-game Lumosity brain exercise experience in busy clinical areas to obtain a quick, quantitative measure of cognitive reserve (first gameplay performance [FGP]) in older patients presenting for major surgery. Participants in this feasibility trial will serve as a pilot population to estimate postoperative delirium incidence in patients willing and able to complete the brief, self-directed, brain exercise experience on a portable electronic device in various preoperative encounters, and will provide insight into which preoperative encounter (outpatient clinic or morning of surgery preoperative holding) may be more conducive to brief preoperative cognitive evaluations and interventions in future studies. First gameplay performance obtained during study procedures will be compared based upon postoperative delirium status (positive verse negative) to evaluate predictive value of the custom 6-game battery. This will guide future studies of FGP as a quick, quantitative measure of cognitive reserve in older surgical patients, with potentially more utility in preoperative patients than other assessments of cognitive function.
Detailed description
Potential study participants will be identified by researchers monitoring The Ohio State University Preoperative Assessment Clinic (OPAC) and operating room (OR) schedules. Eligible patients will be contacted over-the-phone regarding willingness to participate. Surgeons will be made aware when their patients have been approached over the phone and updated accordingly if the patient agrees to be enrolled in the study. If willing, patients will be met at either their preoperative assessment at OPAC or their day of surgery at Preoperative Holding. Patients will be screened at this encounter for inclusion and exclusion criteria.
Following the initial screening encounter, patients will be required to provide informed consent prior to any study activities or data collection. Once informed consent is signed by both the subject and researcher, the researcher will provide the patient with a portable electronic device (laptop) with access to Lumosity brain exercise software (Lumos Labs, San Francisco, California, USA) and instruct participants to complete as many of the provided 6 games as possible. These 6 games were identified specifically from preliminary data indicating their postoperative delirium predictive capacity. Gameplay completion and performance scores will be coded and stored on the Lumosity software. Personal health information will not be used on the research device.
At this visit, the researcher will also collect demographic information (age, sex, body max index (BMI), ethnicity, and educational level) and relevant comorbidities via the Charlson Comorbidity Index (CCI). The research device will be collected at the end of the patient's visit at OPAC or just prior to surgery when in preoperative holding.
All patients will undergo surgery as planned. Time under anesthesia and type of surgery will be collected. On the first day following surgery, patients will be assessed by research members for the presence of delirium using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) at 0800 ± 2 hours and 1700 ± 2 hours. This will be repeated every postoperative day until postoperative day 7 or discharge, whichever comes first. Additionally, medical notes from the day of surgery to discharge or post-operative day (POD) 7 (whichever comes first) will be assessed for delirium by a researcher using a validated medical chart-based delirium assessment (CHART-DEL). Patients will be asked to complete the Discharge Survey Prior to hospital discharge or over the phone after discharge. In addition, their length of stay in the hospital and discharge location will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPAC | – | Device: Brain exercise gameplay on a portable electronic deviceFeasibility to conduct brain exercise gameplay on a portable electronic device at Ohio State Preoperative Assessment Clinic (OPAC) |
| PREOP | – | Device: Brain exercise gameplay on a portable electronic deviceFeasibility to conduct brain exercise gameplay on a portable electronic device at The Wexner Medical Center Preoperative Holding Areas. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 60 years of age or older, capable and willing to consent and scheduled to undergo non-cardiac/non-neurological surgery with an expected hospital stay of at least 72 hours.
Key inclusion criteria (6 listed)
- 60 years of age or older
- Capable and willing to consent
- Non-cardiac/non-neurological surgery with an expected hospital stay of at least 72 hours
- Anticipated ASA physical status I-IV
- English speaking
Key exclusion criteria (7 listed)
- Severe visual or auditory deficits
- Illiterate
- Surgery or procedure within the previous 6 months requiring general anesthesia
- Active Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol, or drug abuse
- ASA physical status V, VI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain exercise gameplay on a portable electronic deviceFeasibility is defined as a 70% completion rate for at least 3 of the six brain exercise games in study participants from which a 'first gameplay score' can be determined. Investigators will also assess level of satisfaction with the brain exercise intervention and barriers to playing in the busy preoperative clinical settings as evaluated by a patient-centered questionnaire (Discharge Survey). | Device | OPAC, PREOP |
Primary outcome
Incidence of Lumosity 6-game brain exercise completion
Time frame: up to 30 minutes after participants start the first Lumosity game brain exercise
Determine if brain exercise gameplay on a portable electronic device is feasible in two different preoperative settings (The Ohio State Preoperative Assessment Clinic (OPAC) and The Wexner Medical Center Preoperative Holding Areas).
1 secondary outcome
Incidence of Postoperative Delirium
Time frame: through study completion, an average of 7 days
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 25 Feb 2026.
- Individual participant dataSharing planned: Undecided. The proportion (95% confidence interval) of patients successfully completing at least three games will be estimated overall and in each setting. Investigators will additionally summarize the total number of games played overall and in each setting. Questionnaire results will be summarized in each setting as absolute data with 0: strongly disagree, 25: disagree, 50: neutral, 75: agree, and 100: strongly agree.
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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 Decline, run by Ohio State University at 1 site in United States.
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 6 inclusion and 7 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 25 Feb 2026. 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 United States. 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?
Incidence of Lumosity 6-game brain exercise completion (time frame: up to 30 minutes after participants start the first Lumosity game brain exercise). 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 25 Feb 2026.