Video game-based digital medicine is being studied at Vanderbilt University Medical Center as a potential treatment for COVID-19 survivors who experience impaired cognitive function, or "brain fog," after their recovery.
Cognitive impairments such as issues with attention, focus and concentration are the most common symptom in post-COVID "long haulers," but there are currently no approved treatments.
VUMC and Akili are partnering to evaluate the FDA-approved digital therapeutic AKL-T01 in patients through an action video game experience that presents specific sensory stimuli and simultaneous motor challenges designed to target and activate the neural systems that play a key role in attention function.
"The chronic symptoms of COVID-19 long haulers represent a serious and growing public health concern that will linger long after the acute nature of COVID-19 has passed," said James Jackson, PsyD, assistant director of the ICU Recovery Center at VUMC and lead psychologist for the The Critical Illness, Brain Dysfunction and Survivorship (CIBS) Center at the Vanderbilt University School of Medicine.
"We're excited by the potential of targeted digital therapeutics that target cognitive impairments to help COVID-19 survivors," he said.
Clinical recruitment for the study is anticipated to begin in the next month, Jackson said.
"This study will also help define how COVID is impacting the community by defining how many people struggle with brain fog after an infection," said Keipp Talbot, MD, MPH, associate professor of Medicine in the Division of Infectious Diseases at VUMC.
VUMC's research team will work with Akili to conduct a randomized, controlled clinical study evaluating AKL-T01's ability to target and improve cognitive functioning in approximately 100 COVID-19 survivors ages 18+ who have exhibited a deficit in cognition. Half of the study participants will receive four weeks of digital treatment and half will serve as a control group.
The study's primary endpoint is mean change in cognitive function, as measured by CNS Vital Signs (composite score of cognitive function, especially attention and processing speed). Secondary endpoints include additional measures of cognitive functioning. The study will be conducted remotely in patients' homes.
"As frontline health care workers continue to fight the immediate acute symptoms of Covid-19, certain longer-term consequences of the illness are beginning to emerge, including serious cognitive impairments," said Akili Chief Medical Officer Anil Jina, MD.
"With more than 96 million infections globally and counting, the potential impact of long-term cognitive impairments in even a subset of the