Vanderbilt University Medical Center will study adult survivors of medical and surgical intensive care at high risk for long-term cognitive impairment to see if computerized cognitive rehabilitation (CCR) is effective in improving cognition in ICU survivors who often have trouble doing complex tasks, maintaining their finances and staying employed.
The first-of-its-kind study, set to begin this winter, comes at a time when there’s a larger-than-ever number of survivors of intensive care because of the worldwide COVID-19 pandemic.
The greatest indicator of whether someone will have cognitive deficits after an ICU stay is whether they have delirium (confusion) while in the ICU, said Mayur Patel, MD, MPH, associate professor of Surgery and principal investigator of the study along with Wes Ely, MD, MPH, Grant Liddle Professor of Medicine.
Millions of patients in intensive care units each year develop delirium during their hospitalization and often leave the hospital with cognitive deficits similar to those suffering from traumatic brain injury or mild Alzheimer’s disease.
“One-third to one-half of ICU survivors have some level of cognitive impairment,” Patel said. “They have difficulty managing finances, personal and social relationships and maintaining employment. Of those who were previously employed, about half regain employment after surviving a critical illness event.”
The study, Returning to Everyday Tasks Utilizing Rehabilitation Networks (RETURN) III, expands on two prior studies (RETURN I and II) of cognitive rehabilitation intervention.
The RETURN III trial is a yearlong study that will randomize 160 medical and surgical Nashville VA ICU survivors evenly into two groups: the intervention group using CCR for 12 weeks or a group that uses non-specific computer games like Solitaire or Candy Crush.
For almost two decades, VUMC researchers have been studying ICU patients on ventilators and modifying their treatment to combat the debilitating effects of delirium, the sudden disruption of consciousness marked predominantly by inattention and sometimes by vivid hallucinations and delusions.
Ely and his colleagues at Vanderbilt and the VA have identified delirium as one of the most critical problems facing ICU patients — linked with increased deaths, prolonged ICU and hospital lengths of stay and significantly higher medical costs.
There’s now a center behind the researchers’ study of delirium and dementia — the Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center — directed by Ely and Pratik Pandharipande, MD, MSCI, professor of Anesthesiology.
It’s composed of an interprofessional group of physicians, nurses, psychologists, biostatisticians, epidemiologists, pharmacists, physical and occupational therapists and trainees.
The center’s team members work with patients who are, or have been, critically ill and who have suffered from delirium and are at risk for long-term cognitive, functional and neuropsychological impairments.
Mina Nordness, MD, a surgical resident working with the CIBS center, is helping organize and launch the RETURN III study with CIBS Center Long-Term Outcomes (LTO) Core Leader Amy Kiehl, MA, LPC-MHSP and James Jackson, PhD, director of the CIBS LTO Core. She said the hope is that the CCR intervention will improve cognition as well as brain structure in the participants.
The CCR intervention was developed by Michael Merzenich, PhD, an Institute of Medicine member, leading pioneer in brain plasticity research, and co-founder of the company, Posit Science, where he serves as chief scientific officer.
The CCR games focus on things like processing speed and attention. The games become more difficult as the individual progresses.
“The goal is to serially stretch the mind, to keep challenging it, to really harness the plasticity of neurons and related networks,” Patel said. “Our mindset is even if there’s damage related to the critical illness process there are ways to rewire, relearn, adapt and regain function.”
Participants will have a baseline MRI at the time of discharge from the ICU. They will be seen immediately after the 12-week intervention, then again at one year where they will receive another MRI. The second MRI will look to see whether there are any structural changes to the brain in the group using the CCR intervention.
“The goal is to see the effect right after the intervention and to see if it’s durable, if it lasts,” Nordness said.
“Our goal, especially in light of the current situation (COVID-19 pandemic) and how many ICU patients and ultimately survivors there are going to be, is to find out if this intervention has some benefit, something that is readily available to individuals at risk,” Nordness said.
“If so, they could be counseled on these options at discharge from the ICU. Right now, all we know is that 30 to 50% of ICU survivors have life-altering cognitive impairment, but nobody has been able to show an intervention that has helped them.”
Others involved in the RETURN III trial include Sarah Welch, DO, a resident in Physical Rehabilitation and Medicine and VA Quality Scholar.
The study is funded by the VA Merit Award (IO1 RX002992) funding mechanism from the VA Office of Rehabilitation Research and Development.
