Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)

Summary

Many individuals experience an acute change in thinking and reasoning skills after surgery. This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study is to determine if performing mental exercise, before surgery, will help reduce post-surgery memory and thinking problems. Assuming a 30% incidence of PD and proposed 50% reduction of PD in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I error rate. Assuming approximately 1/3 of consented patients either fail screening or do not complete the study after consent, we expect to consent 358 patients.

At least 8 days before surgery, subjects complete a series of questionnaires to assess baseline cognition level (or thinking ability) and status of overall well-being. At the completion of the screening visit, qualifying subjects are randomized into two groups:

Participants randomized into the Cognitive Exercise group are expected to complete tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for the duration of the preoperative period. Participants in this group are expected to complete a minimum of 10 hours within at least 8 days prior to surgery.

Participants randomized into the Normal Activity group are encouraged to carry out their baseline daily activities, and do not have any study-related cognitive exercise expectations before surgery. These subjects still complete the same questionnaires and assessments as the Cognitive Exercise group throughout the study, however, are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are not permitted to subscribe to Lumosity while in the research study.

On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is taken before surgery. During surgery, research personnel monitor vital signs and medications given. After surgery, another CAM evaluation is taken in the post-operative recovery room.

Throughout the subject's hospital stay, pain levels and medication usage are recorded. The CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity of PD. The evaluations are given twice daily, at at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs, for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of Recovery Scale (PQRS) is used each post-operative day at 6:30PM ± 1.5 hrs until discharge, and completed over the phone on POD 7 if patient discharged. The PQRS is also administered over the phone on POD 30 and POD 90.

Conditions

• Delirium

Interventions

OTHER

Mini-Mental State Examination

To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)

OTHER

Self-Administered Gerocognitive Examination

To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)

OTHER

Geriatric Depression Scale

To be completed at the Screening Visit and at POD 90

OTHER

Charlson Comorbidity Index

To be completed at the Screening Visit and at POD 90

OTHER

Short Form 36 Health Survey

To be completed at the Screening Visit

OTHER

Confusion Assessment Method

To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)

OTHER

Memorial Delirium Assessment Scale

To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)

OTHER

Postoperative Quality of Recovery Scale

To be completed at Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 6:30PM ± 1.5 hrs (or until hospital discharge). Will be completed POD 7 over the phone if patient already discharged. Will be completed on POD 30 and POD 90.

Sponsors & Collaborators

• Ohio State University

  lead OTHER

Principal Investigators

• Michelle L Humeidan, MD,PhD · Ohio State University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2019-05-20

Completion

2019-08-20

Countries

• United States

Study Locations