SCHIZOPHRENIA 1 (Disorder)IVR SCZNCT07427485
Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomized Waiting List Controlled Feasibility Study
A study testing CEREBRUM VR and Waiting List in people with SCHIZOPHRENIA 1 (Disorder) and Schizoaffective Disorder, run by Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- SCHIZOPHRENIA 1 (Disorder), Schizoaffective Disorder
- What is being tested?
- CEREBRUM VR and Waiting List
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 11 Mar 2025to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with Schizophrenia/Schizoaffective Disorder (DSM-5-TR)
- Age 18-67 years
- Chronic phase of illness
- Able to provide a valid informed consent
Who cannot join
- Recent substance use (less than six months)
- Concomitant intellectual disability or neurological disorders (e.g., neurodegenerative disorders, Parkison's disease, brain cancer) that may impair the ability to undergo cognitive rehabilitation
- With a recent (less than six weeks from the enrolling date) symptom exacerbation, hospitalization or change in pharmacotherapy
- Acute phase of illness
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Sanitaria Locale Napoli 3 Sud Unità Operativa Complessa Salute Mentale Torre del Greco/Ercolano
Torre del Greco, Naples, 80059
About this study
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.
- Being tested
- CEREBRUM VR, Waiting List
- Keywords
- rehabilitation, cognitive remediation, community mental health
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEREBRUM VRDevice
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.
Waiting ListOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality-Based Cognitive Rehabilitation | Experimental | patients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU) Receives: Device: CEREBRUM VR |
| Waiting List | Other | The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU Receives: Other: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start11 Mar 2025
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SCHIZOPHRENIA 1 (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427485
- Sponsor's protocol ID
- 29475 - 02/03/2025
- Acronym
- IVR SCZ
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Angelov V, Petkov E, Shipkovenski G, Kalushkov T, editors. Modern virtual reality headsets. 2020 International congress on human-computer interaction, optimization and robotic applications (HORA); 2020: IEEE.
Primavera D, Migliaccio GM, Garau V, Orru G, Scano A, Perra A, Pinna S, Tusconi M, Carta MG, Sancassiani F. Improving Quality of Life in Bipolar Disorders with an Immersive Virtual Reality Remediation Training Randomized Controlled Trial (RCT). J Clin Med. 2024 Jul 2;13(13):3886. doi: 10.3390/jcm13133886.
PubMed 38999451Caiazza C, Aletto A, Franzese L, Mazza D, Marino F, Rossano F, De Mare I, Rago V, Rocca BD, Manzo M, Toni C, Luciano M, Rago V, Fiorillo A. Cognitive rehabilitation with immersive virtual reality in schizophrenia: A randomized waiting list-controlled study. Schizophr Res Cogn. 2026 Aug 3;46:100458. doi: 10.1016/j.scog.2026.100458. eCollection 2026 Sep.
PubMed 42568860
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomized Waiting List Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT07427485
- Acronym / sponsor ID
- IVR SCZ / 29475 - 02/03/2025
- Keywords
- rehabilitation, cognitive remediation, community mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del GrecoUniversity, hospital or other
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality-Based Cognitive Rehabilitation | Experimental | Device: CEREBRUM VRpatients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU) |
| Waiting List | Other | Other: Waiting ListThe patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with Schizophrenia/Schizoaffective Disorder (DSM-5-TR)
- Age 18-67 years
- Chronic phase of illness
- Able to provide a valid informed consent
Key exclusion criteria (4 listed)
- Recent substance use (less than six months)
- Concomitant intellectual disability or neurological disorders (e.g., neurodegenerative disorders, Parkison's disease, brain cancer) that may impair the ability to undergo cognitive rehabilitation
- With a recent (less than six weeks from the enrolling date) symptom exacerbation, hospitalization or change in pharmacotherapy
- Acute phase of illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEREBRUM VRThe 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. | Device | Immersive Virtual Reality-Based Cognitive Rehabilitation |
| Waiting ListParticipants 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. | Other | Waiting List |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: From enrollment to the end of treatment at 12 weeks
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.)
6 secondary outcomes
Digit Symbol Substitution Test (DSST)
Time frame: From enrollment to the end of treatment at 12 weeks
Animal Naming Test (ANT)
Time frame: From enrollment to the end of treatment at 12 weeks
Trail Making Test - A (TMT)
Time frame: From enrollment to the end of treatment at 12 weeks
Simple Reaction Time (SRT)
Time frame: From enrollment to the end of treatment at 12 weeks
Choice Reaction Time (CRT)
Time frame: From enrollment to the end of treatment at 12 weeks
Global Assessment of Functioning (GAF)
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- BackgroundAngelov V, Petkov E, Shipkovenski G, Kalushkov T, editors. Modern virtual reality headsets. 2020 International congress on human-computer interaction, optimization and robotic applications (HORA); 2020: IEEE.
- Background: PubMed 38999451Primavera D, Migliaccio GM, Garau V, Orru G, Scano A, Perra A, Pinna S, Tusconi M, Carta MG, Sancassiani F. Improving Quality of Life in Bipolar Disorders with an Immersive Virtual Reality Remediation Training Randomized Controlled Trial (RCT). J Clin Med. 2024 Jul 2;13(13):3886. doi: 10.3390/jcm13133886.
- Derived from this study: PubMed 42568860Caiazza C, Aletto A, Franzese L, Mazza D, Marino F, Rossano F, De Mare I, Rago V, Rocca BD, Manzo M, Toni C, Luciano M, Rago V, Fiorillo A. Cognitive rehabilitation with immersive virtual reality in schizophrenia: A randomized waiting list-controlled study. Schizophr Res Cogn. 2026 Aug 3;46:100458. doi: 10.1016/j.scog.2026.100458. eCollection 2026 Sep.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEREBRUM VR and Waiting List in people with SCHIZOPHRENIA 1 (Disorder) and Schizoaffective Disorder, run by Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07427485, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.