Virtual reality to help recovery after intensive care (PICS)
Virtual Reality Intervention for Post-Intensive Care Syndrome (PICS): A Protocol for a Pilot Randomized Controlled Trial for Cognitive, Physical and Psychological Outcomes
This study will try whether immersive virtual-reality brain-training helps adults recovering from ICU-related memory and thinking problems improve more than the same games on a tablet or usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minho Academic / other |
| Locations | 1 site (Porto, Porto District) |
| Trial ID | NCT07585500 on ClinicalTrials.gov |
What this trial studies
Adults who recently stayed in the ICU and are at risk for Post‑Intensive Care Syndrome are randomized 1:1:1 to one of three arms: immersive VR using a Meta Quest Pro with six targeted cognitive games, the identical games delivered on a 2D tablet, or standard care without digital exercises. Participants complete short daily brain-training sessions (about 12 minutes per day) while in the hospital, with the protocol aimed at early cognitive rehabilitation. The trial is designed to test the "Immersion Hypothesis," i.e., whether full sensory immersion provides extra neurological engagement beyond the games themselves. Outcomes focus on memory, attention, processing speed, and other cognitive domains relevant to ICU recovery.
Who should consider this trial
Good fit: Adults (18+) currently in the ICU who are post‑extubation if ventilated, have a RASS between -1 and +1, can sit semi‑upright and move both arms enough to interact, can communicate in Portuguese, have a projected hospital stay of at least four more days, and provide informed consent (or through a legal representative).
Not a fit: Patients with severe neurodegenerative disease, major unresolved brain injury or severe psychiatric conditions requiring institutionalization, those unable to communicate or move safely, or those who cannot tolerate sitting or wearing a headset are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could speed recovery of memory and thinking skills after an ICU stay and help survivors return to daily life sooner.
How similar studies have performed: Some small trials of VR in other rehabilitation settings have shown cognitive or engagement benefits, but using immersive VR specifically for PICS and early ICU cognitive rehab is relatively novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients, 18 years or older * Patients in the Intensive Care Unit * Ventilated patients must be in the post-extubation period * The patient has a projected remaining hospital stay of at least 4 days (assessed by the clinical team) * The patient has RASS score between -1 and +1 * The patient has the ability to move both arms, even if with difficulties, as assessed by the clinical team, to be able to interact with the software * The patient can maintain a stable sitting position (30° to 60°) * The patient is able to communicate (speech, gesturing, or writing) * The patient can communicate and understand Portuguese * The patient or a legal representative provided informed consent Exclusion Criteria: * Severe cognitive and neurodegenerative diseases: mental illness requiring institutionalization; acquired or congenital intellectual disability; known severe brain injuries (e.g., stroke with significant residual deficits); moderate to severe Traumatic Brain Injury (TBI) (defined by the duration of loss of consciousness/post-traumatic amnesia or documented residual deficits); diagnosed neurodegenerative diseases (e.g., Parkinson's disease with severe movement impairment, Huntington's disease, severe Alzheimer's disease, or dementia of any etiology that prevents autonomy in daily life at baseline) * The patient uses neuromuscular blocking agents * The patient has a positive CAM-ICU result at the time of initial screening * The patient has active psychotic disorders or suicidal ideation * The patient has documented epilepsy or history of seizures * The patient has a "Do Not Resuscitate" (DNR) order, is on life support with exclusive focus on comfort, or has an unexpected survival predicted to be less than 24 hours * The patient has intoxication by an active substance or withdrawal syndrome requiring ongoing medical management that prevents safe and meaningful participation or accurate cognitive assessment * Patients with immobility or severe motor limitations in the upper limbs, fine motor skills, or cervical region * The patient has open wounds on the head or face that may affect the comfortable/safe use of VR glasses, cause discomfort, or present a hygiene risk * The patient has uncorrected blindness or deafness that prevents the safe/effective use of VR/tablet devices. * Patients are participating in another rehabilitation study with interventions * Patients with a scheduled surgery where the ICU stay is expected to be less than 24 hours * Patients in need of respiratory support
Where this trial is running
Porto, Porto District
- Centro Hospitalar Universitário São João — Porto, Porto District, Portugal (Recruiting)
Study contacts
- Principal investigator: João Ferreira-Coimbra, MD — Centro Hospitalar De São João, E.P.E.
- Study coordinator: Nuno F. Rodrigues
- Email: nunofeixa@gmail.com
- Phone: 929145931
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.