An interventional study of CEREBRUM VR and Waiting List in SCHIZOPHRENIA 1 (Disorder) and Schizoaffective Disorder, sponsored by Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco. Completed at 1 site in Italy. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco · Not applicable, Interventional, and Treatment
Virtual reality-based rehabilitation has recently gained increasing attention in the field of cognitive rehabilitation, allowing patients to engage in simulated real-life scenarios within a safe and controlled setting. The feasibility and safety of immersive VR-based cognitive rehabilitation in individuals with schizophrenia is currently insufficiently explored. This study seeks to evaluate whether immersive immersive virtual reality-based rehabilitation can be safely and practically implemented in a community psychiatric setting. The study also aims to explore preliminary effects on negative symptoms, cognitive performance, and global functioning compared with treatment as usual in a waiting-list control group.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →This is the only study on the registry with Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco as lead sponsor.
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Exclusion Criteria:
patients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU)
Device: CEREBRUM VR
The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU
Other: Waiting List
The Oculus Quest 3 Virtual Reality Headset, two joysticks, and the CEREBRUM - Virtual Cognitive Rehabilitation add-on tool are employed for the immersive virtual reality cognitive rehabilitation. The headset allows for an IVR 360° experience with spatial tracking and ability to free-roam in the virtual reality space. The aforementioned tool simulates real-life everyday scenarios, engaging different domains including memory and learning, cognitive estimates, metacognition and social interaction, attention and working memory, and planning. The Cerebrum protocol also allows for a personalized and adaptive difficulty based on each individual's abilities. Each session consists in a welcoming and 4-5 exercises from different domains. Each session is supervised by a Psychiatric Rehabilitation Professional.
Participants will to not receive the IVR-based rehabilitation, but rather will be offered after the study ends. They will continue with their therapy as usual.
Positive and Negative Syndrome Scale (PANSS)
Total score, positive and negative symptoms, general psychopathology. 30-item clinician-rated tool used to measure symptom severity in schizophrenia that ranges from 30pts. to 210pts (Total score). Higher values indicate higher severity. It includes three subscales: Positive, Negative (both range 7-49pts), and General Psychopathology (range 16-112pts.)
Time frame: From enrollment to the end of treatment at 12 weeks
Digit Symbol Substitution Test (DSST)
It measures processing speed. The score reflects the total number of correctly substituted symbols for corresponding single digit numbers during a 90-second timeframe. The score ranges from 0 upwards, with no theoretical limit. Higher score indicate better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
Animal Naming Test (ANT)
1-minute verbal fluency assessment requiring participants to name as many animals as possible in a 60 sec timeframe. Score can range from 0 to a theoretically unlimited maximum. Greater scores indicate better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
Trail Making Test - A (TMT)
Neuropsychological test to measure cognitive processing speed, visual scanning, and attention. It involves connecting 25 numbered circles in the least amount of time, evaluated in seconds. Score can range from 0 to a theoretically unlimited maximum. Lower time scores indicate better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
Simple Reaction Time (SRT)
It measures the psychomotor speed and is the minimal time required for an individual to detect a predictable sensory stimulus (an X on the screen) and initiate a motor response (i.e., pressing a button on the keyboard). Scores range from 0 to a theoretically unlimited maximum. It is evaluated in milliseconds (ms) and lower scores indicate a better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
Choice Reaction Time (CRT)
It is the interval between the presentation of one of several different stimuli and the initiation of a specific response (i.e., pressing the correct corresponding button on the keyboard). It measures cognitive processing speed, and score ranges from 0 to a theoretically unlimited maximum. Lower scores indicate better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
Global Assessment of Functioning (GAF)
It is a numeric scale (0-100) used to rate a person's overall psychological, social, and occupational functioning. Higher scores indicate a better performance.
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: Undecided — The decision regarding the possibility of sharing of individual participant data (IPD) will be made in accordance with institutional policies, applicable data protection regulations (including GDPR), and ethical approvals governing the study. Given the pilot nature of the trial and the collection of sensitive health-related data, any potential data sharing will require careful evaluation to ensure adequate anonymization and protection of participant confidentiality.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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