160 Participants Needed

Computerized Cognitive Rehabilitation for ICU Survivorship

(RETURN-III Trial)

Recruiting at 1 trial location
EW
MB
Overseen ByMayur B Patel, MD MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What data supports the effectiveness of the treatment Computerized Cognitive Rehabilitation for ICU Survivorship?

Research shows that early cognitive rehabilitation training can significantly improve planning, decision-making, and executive function in ICU patients with cognitive impairment. Additionally, early rehabilitation in the ICU may reduce complications associated with post-intensive care syndrome, which includes cognitive impairments.12345

Is computerized cognitive rehabilitation safe for humans?

Research on computerized cognitive rehabilitation, including studies on brain injury and stroke patients, shows it is generally safe. Some patients experienced mild side effects like mental fatigue, headache, and eye irritation, but overall, it was well-tolerated.678910

How is Computerized Cognitive Rehabilitation different from other treatments for ICU survivorship?

Computerized Cognitive Rehabilitation is unique because it uses computer programs to help improve cognitive functions like memory and attention, offering a flexible and individualized approach compared to traditional methods like pen and paper exercises. This treatment is particularly novel as it allows for personalized therapy that can be adjusted to the specific needs of each patient, potentially enhancing recovery outcomes.910111213

What is the purpose of this trial?

Millions of patients survive care in medical and surgical Intensive Care Units (ICUs) every year, only to suffer from a new or accelerated dementia-like process, called post-ICU long-term cognitive impairment (ICU-LTCI). ICU-LTCI causes considerable problems with personal relationships, return to work, and everyday tasks, such as managing medicines and money. No treatment for these patients is currently available. Technology using computerized cognitive rehabilitation could improve ICU-LTCI by harnessing the healing potential of the brain (i.e., neuroplasticity). This intervention is scalable, portable, and economical. The investigators will evaluate the effectiveness of computerized cognitive rehabilitation in a randomized controlled trial of 160 VA patients with ICU-LTCI. The investigators hypothesize that this intervention could improve cognition, and brain structure shown by MRI. This research has high potential to influence rehabilitation strategies for Veteran and civilian ICU survivors.

Research Team

EW

E. Wesley Ely, MD MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

MB

Mayur B Patel, MD MPH

Principal Investigator

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN

Eligibility Criteria

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

I was recently in the ICU for severe breathing problems or shock.
No longer requiring ICU-level care

Exclusion Criteria

Homeless without a secondary contact available
You have a severe substance abuse problem or mental illness that makes it difficult for you to live independently.
I am currently having thoughts about harming myself.
See 8 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Computerized Cognitive Rehabilitation or active control computer games

12 weeks

Follow-up

Participants are monitored for cognitive improvements and safety post-treatment

12 months
Assessments at 3 and 12 months post-randomization

Treatment Details

Interventions

  • Computerized Cognitive Rehabilitation
Trial Overview The RETURN-III trial tests computerized cognitive rehabilitation on patients with post-ICU cognitive impairment. Participants will be randomly assigned to either play control computer games or undergo targeted cognitive rehab exercises designed to improve brain function and structure.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Computerized Cognitive RehabilitationExperimental Treatment1 Intervention
Computerized Cognitive Rehabilitation
Group II: Active Control computer gamesActive Control1 Intervention
Active Control computer games

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+

Findings from Research

Long-term cognitive impairment affects up to 60% of ICU survivors, highlighting the need for early functional and cognitive rehabilitation interventions during their ICU stay.
This systematic review aims to evaluate various rehabilitation interventions and their impact on cognitive function, quality of life, and mortality rates 6-12 months post-ICU discharge, setting the stage for future clinical trials.
Functional and cognitive rehabilitation interventions during intensive care admission: A protocol for a systematic integrative review.Collet, MO., Laerkner, E., Jensen, J., et al.[2023]
A pilot study involving 87 ICU patients showed that early cognitive therapy combined with physical therapy was feasible and safe, with 95% of patients receiving the cognitive therapy as planned.
Despite the successful implementation of the therapy, there were no significant differences in cognitive, functional, or quality of life outcomes among the different treatment groups at the 3-month follow-up, indicating that further research is needed to assess the benefits of cognitive therapy in critically ill patients.
Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial.Brummel, NE., Girard, TD., Ely, EW., et al.[2023]
Early rehabilitation interventions in the ICU can significantly reduce the physical and mental health impairments associated with post-intensive care syndrome (PICS), which can negatively affect survivors' quality of life.
Effective rehabilitation requires a multidisciplinary team approach and consideration of factors such as safety, feasibility, and available resources, with specific mental health strategies including ICU diaries and coping skills training.
Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments.Parker, A., Sricharoenchai, T., Needham, DM.[2022]

References

Functional and cognitive rehabilitation interventions during intensive care admission: A protocol for a systematic integrative review. [2023]
Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. [2023]
Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. [2022]
Effects of early cognitive rehabilitation training on cognitive function and quality of life in critically ill patients with cognitive impairment: A randomised controlled trial. [2023]
Feasibility and safety of virtual-reality-based early neurocognitive stimulation in critically ill patients. [2020]
Perceived Facilitators and Barriers to Treatment Fidelity in Computerized Cognitive Training Interventions. [2023]
Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial. [2022]
A customized home-based computerized cognitive rehabilitation platform for patients with chronic-stage stroke: study protocol for a randomized controlled trial. [2023]
Effect of computerized cognitive rehabilitation in comparison between young and old age after traumatic brain injury. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]
[Microcomputer and rehabilitation of cognitive cerebral performance disorders]. [2015]
Computer-based cognitive rehabilitation: the CoRe system. [2018]
Computer-based cognitive rehabilitation research in a military treatment facility: Recruitment, compliance, and lessons learned. [2018]
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