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

Conditions Phase Intervention Type
    Delirium
N/A
Other
Mini-Mental State Examination
Self-Administered Gerocognitive Examination
Geriatric Depression Scale
Charlson Comorbidity Index
Confusion Assessment Method
Memorial Delirium Assessment Scale
Short Form 36 Health Survey
Postoperative Quality of Recovery Scale

Eligibility

Ages Eligible for Study
60 years and up
Genders Eligible for Study
Both

Keywords

Delirium, Post Operative Delirium, PD, POD, Anesthesia, Anesthesiology, Post Operative Recovery, Post Anesthesia Care Unit, PACU, Cognition, Cognitive Impairment, Memory, Thinking, Confusion Assessment Method, CAM, Neurobics, Neuroplasticity, Lumosity, Brain Games, Cognitive Exercise, Cognitive Training, Perioperative Cognitive Protection, Cognitive Reserve, Neurobics Trial, Surgery, and Elderly Patients

Sponsors

Other
Ohio State University

Inclusion Criteria

1. 60 years of age or older

2. Capable and willing to consent

3. Non-cardiac/non-neurological surgery with expected hospital stay of at least 72 H

4. American Society of Anesthesiologists (ASA) physical status I-IV

5. English speaking

6. Willingness to use a provided tablet device

7. Willingness to commit at least 1 hour per day to experimental intervention (cognitive
activity/exercise) to complete a minimum of 10 hours within at least 8 days prior to
surgery.

Exclusion Criteria

1. Severe visual or auditory deficits

2. Illiterate

3. Surgery within the previous 6 months requiring general anesthesia

4. Score < 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for
patients with less than high school education)

5. Positive pre-surgery Confusion Assessment Method test (CAM)

6. Active depression as indicated by Geriatric Depression Scale screening test (score ≥
10)

7. History of Axis I or II psychiatric disorders including bipolar disorder,
schizophrenia, dementia, alcohol or drug abuse

8. ASA physical status V, VI

9. Planned postoperative intubation

Detailed Description

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02230605

Locations

  • The Ohio State University Wexner Medical Center
    Columbus, Ohio United States

    Status: Recruiting

    Contact info Michelle L Humeidan, MD, PhD
    614-293-7308

Overall Contact Backup

Michelle L Humeidan, MD, PhD
614.293.7308