Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study

NCT06245005 | Completed

• 1 other identifier: 2022H0419
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• 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).

  up to 30 minutes after participants start the first Lumosity game brain exercise

Secondary Outcomes (1)

• Incidence of Postoperative Delirium

  through study completion, an average of 7 days

Study Arms (2)

OPAC

Feasibility to conduct brain exercise gameplay on a portable electronic device at Ohio State Preoperative Assessment Clinic (OPAC)

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.

Device: Brain exercise gameplay on a portable electronic device

Interventions

Brain exercise gameplay on a portable electronic device DEVICE

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).

OPAC; PREOP

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 7, 2024
• Study Start: September 20, 2023
• Primary Completion: September 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

US (1)