Computerized Cognitive Rehabilitation for ICU Survivorship
(RETURN-III Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist individuals with cognitive problems, such as memory and thinking issues, after an ICU stay. The treatment uses computerized cognitive rehabilitation, which employs brain exercises to potentially improve these issues by leveraging the brain's ability to adapt and heal. Researchers aim to determine if this approach offers more benefits than regular computer games. The trial seeks adults who recently stayed in an ICU due to serious conditions like respiratory failure or shock and are now facing cognitive challenges. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that computerized cognitive rehabilitation is generally safe. Studies involving individuals with brain injuries and strokes have demonstrated that this therapy is well-tolerated. For instance, a small study found that people recovering from serious illnesses with cognitive problems experienced significant improvements without major safety issues. Although detailed safety data from large groups is not yet available, the positive results so far are encouraging. This suggests that the treatment could be a safe option for those seeking to improve thinking skills after ICU stays.12345
Why are researchers excited about this trial?
Researchers are excited about computerized cognitive rehabilitation for ICU survivors because it offers a novel approach to tackling cognitive impairments that many patients experience after intensive care. Unlike traditional cognitive therapies that might involve face-to-face sessions with a therapist, this method uses digital platforms to deliver cognitive exercises, making it more accessible and potentially more engaging for patients. Additionally, this computerized approach can be easily customized to target specific cognitive deficits, providing a personalized therapy experience. By leveraging technology, this treatment has the potential to reach a larger number of patients, offering them an opportunity for cognitive recovery that fits into their daily lives more seamlessly.
What evidence suggests that computerized cognitive rehabilitation is effective for ICU-LTCI?
Research has shown that computer-based exercises can greatly enhance thinking and memory in survivors of serious illnesses. In this trial, participants will join one of two groups: one group will receive Computerized Cognitive Rehabilitation, which studies have shown significantly improves memory and thinking problems. Another study found that a digital care program not only aided mental function but also enhanced physical and emotional health in seriously ill patients. These findings suggest that this therapy can aid recovery and improve overall care after ICU discharge. Starting cognitive exercises early has also been shown to maintain mental sharpness following an ICU stay. This treatment leverages the brain's ability to change and adapt, known as neuroplasticity, to potentially boost brain health.13467
Who Is on the Research Team?
E. Wesley Ely, MD MPH
Principal Investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Mayur B Patel, MD MPH
Principal Investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Are You a Good Fit for This Trial?
This trial is for adults who've recently been in an ICU due to respiratory failure or shock, are now stable, and live close enough to the study site. It's not for those with severe pre-existing cognitive issues, substance abuse problems that prevent independent living, active suicidal thoughts, or sensory impairments that hinder communication.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Computerized Cognitive Rehabilitation or active control computer games
Follow-up
Participants are monitored for cognitive improvements and safety post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Computerized Cognitive Rehabilitation
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor
Vanderbilt University Medical Center
Collaborator