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NCT02230605 · ClinicalTrials.gov registry record · NA
Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 322
- Enrollment target
NCT02230605 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 322 participants.
The verdict
NCT02230605, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 322 participants
- Enrollment target
Study 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
Interventions
- OTHER Mini-Mental State Examination
- OTHER Self-Administered Gerocognitive Examination
- OTHER Geriatric Depression Scale
- OTHER Charlson Comorbidity Index
- OTHER Short Form 36 Health Survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-08-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02230605
The ClinicalTrials.gov registry entry for NCT02230605 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 322 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mini-Mental State Examination is the first listed.
NCT02230605 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02230605 about?
NCT02230605 is a clinical study titled "Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)". 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 performi...
What is the current status of trial NCT02230605?
This trial is currently completed. It is a NA study. The enrollment target is 322 participants. The study started on 2015-07. Estimated completion is 2019-08-20.
What interventions are being tested in trial NCT02230605?
The interventions under investigation include: Mini-Mental State Examination (OTHER), Self-Administered Gerocognitive Examination (OTHER), Geriatric Depression Scale (OTHER), Charlson Comorbidity Index (OTHER), Short Form 36 Health Survey (OTHER).
Who is sponsoring clinical trial NCT02230605?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
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