SchizophreniaNCT07702526
Eye-Movement Intervention for Cognitive Impairment Across Schizophrenia Spectrum
A study testing Eye-Movement Training in people with Schizophrenia and Cognitive Impairment, run by Shanghai Mental Health Center.
Trial summary
The goal of this clinical trial is to determine whether a gamified eye-movement intervention can improve cognitive function in individuals across the schizophrenia spectrum, including clinical high-risk individuals, first-episode schizophrenia patients, and chronic schizophrenia patients. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Cognitive Impairment, Clinical High Risk for Psychosis
- What is being tested?
- Eye-Movement Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age between 15 and 45 years.
- More than 9 years of education.
- Normal or corrected-to-normal vision without color blindness, color weakness, strabismus, or nystagmus.
- Right-handedness.
- Impaired cognitive performance defined as a T-score <40 in at least one MCCB cognitive domain at baseline.
- Capacity to complete cognitive and eye-tracking assessments.
Show all 10Show fewer
- Clinical high-risk group: Meet psychosis-risk syndrome criteria based on SIPS/SOPS, including attenuated positive symptoms or brief intermittent psychotic symptoms.
- First-episode schizophrenia group: Meet DSM-5 criteria for schizophrenia, with first episode occurring within approximately 2 years of illness onset and minimal prior antipsychotic exposure.
- Chronic schizophrenia group: Meet DSM-5 criteria for schizophrenia, with illness duration ≥5 years and stable treatment status for the previous 6 months.
- Healthy control group: No current or past psychiatric disorders based on MINI 7.0 and no significant depressive symptoms based on the Hamilton Depression Rating Scale. Healthy controls will also meet the same general criteria regarding age, education, handedness, and vision.
Who cannot join
- IQ <70.
- Severe or unstable medical or neurological illness (e.g., stroke, epilepsy, dementia, cardiac disease, or uncontrolled hypertension).
- Substance abuse or dependence.
- Clinically significant laboratory abnormalities.
- Visual or auditory impairments affecting task performance.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of an Eye-Movement Intervention on Cognitive Impairment in Individuals Across Illness Stages of Schizophrenia: Protocol for a Stratified Randomized, Active-Controlled, Assessor-Blinded Trial
The goal of this clinical trial is to determine whether a gamified eye-movement intervention can improve cognitive function in individuals across the schizophrenia spectrum, including clinical high-risk individuals, first-episode schizophrenia patients, and chronic schizophrenia patients. The main questions it aims to answer are:
- Does eye-movement training improve cognitive performance measured by the MATRICS Consensus Cognitive Battery (MCCB)?
- Does eye-movement training improve oculomotor functions and clinical symptoms across different illness stages?
Read more
Researchers will compare an eye-movement intervention group with an active control group receiving matched finger-controlled game training to determine whether the eye-movement intervention produces greater improvements in cognitive function and eye-movement performance.
Participants will:
- Receive either gamified eye-movement training or matched finger-controlled game training for 4 weeks.
- Complete cognitive assessments using the MCCB before and after the intervention.
- Complete standardized eye-tracking tasks, including fixation stability, smooth pursuit, antisaccade, and free-viewing tasks, to evaluate changes in oculomotor control and visual exploration patterns.
- Complete clinical symptom assessments using SOPS or PANSS according to illness stage.
Read the detailed description
This study is a stratified, randomized, active-controlled, assessor-blinded clinical trial designed to evaluate the effects of a gamified eye-movement intervention on cognitive function across the schizophrenia spectrum, including clinical high-risk individuals, first-episode schizophrenia patients, chronic schizophrenia patients, and healthy controls.
Cognitive impairment is a core feature of schizophrenia-spectrum disorders and is associated with poor functional outcomes across illness stages. Eye movements are closely linked to cognitive processes such as attention, working memory, and executive control, suggesting that eye-movement-based training may have potential as a cognitive intervention.
Participants will be stratified by illness stage and randomly assigned in a 1:1 ratio to either an eye-movement intervention group or an active control group receiving matched finger-controlled game training. The intervention targets core oculomotor functions, including fixation control, smooth pursuit, and saccadic eye movements, through structured gamified training tasks. The intervention lasts 4 weeks, with 3-4 sessions per week.
The primary outcome is change in cognitive performance assessed using the MATRICS Consensus Cognitive Battery (MCCB), including composite and domain-specific T-scores from baseline to week 4. Secondary outcomes include changes in oculomotor functions and visual exploration patterns assessed using standardized eye-tracking tasks, including fixation stability, smooth pursuit, antisaccade, and free-viewing paradigms. Clinical symptom severity will be assessed using the Scale of Psychosis-Risk Symptoms (SOPS) for clinical high-risk participants and the Positive and Negative Syndrome Scale (PANSS) for schizophrenia participants.
Statistical analyses will evaluate intervention effects on cognitive, eye-movement, and clinical outcomes, including group-by-time interactions across illness stages.
- Being tested
- Eye-Movement Training, Finger-Controlled Game Training
- Keywords
- Eye movement training, Cognitive remediation, BVMT-R, Visuospatial memory, Eye tracking
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-Movement TrainingBehavioural
A gamified eye-movement training program designed to improve fixation control, smooth pursuit, and saccadic eye movements. The intervention includes three interactive tasks: fixation-based jumping game, gaze-direction control game, and gaze-guided visual tracking game. Participants complete 3-4 sessions per week, approximately 30 minutes per session, for 4 weeks. The intervention is delivered via a computerized eye-tracking system.
Finger-Controlled Game TrainingBehavioural
A gamified finger-controlled training program matched in duration, frequency, visual stimulation, and task structure to the eye-movement intervention. Participants control game actions using finger inputs instead of eye movements. The intervention is designed as an active control to account for non-specific effects including engagement, visual exposure, and task expectancy. Participants complete 3-4 sessions per week, approximately 30 minutes per session, for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Eye-Movement Intervention Group | Experimental | Participants in this group will receive a gamified eye-movement intervention targeting fixation control, smooth pursuit, and saccadic eye movements. The training is delivered through interactive game-based tasks including fixation-based jumping, directional gaze control, and gaze-guided visual tracking. Participants will complete 3-4 sessions per week, with each session lasting approximately 30 minutes, for a total intervention period of 4 weeks. The intervention aims to improve visuospatial attention and cognitive performance. Receives: Behavioral: Eye-Movement Training |
| Active Control Group (Finger-Controlled Game Training) | Active comparator | Participants in this group will receive a finger-controlled gamified training program matched in duration, frequency, visual stimulation, and task structure to the experimental intervention. The training does not involve eye-movement control and serves as an active control condition to account for non-specific effects such as task engagement, visual exposure, and expectancy. Participants will complete 3-4 sessions per week, each lasting approximately 30 minutes, over a 4-week period. Receives: Behavioral: Finger-Controlled Game Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MATRICS Consensus Cognitive Battery (MCCB) Scores
Cognitive function will be assessed using the MATRICS Consensus Cognitive Battery (MCCB), a standardized neurocognitive battery widely used in schizophrenia research. The MCCB consists of nine subtests, including Trail Making Test, Symbol Coding, Hopkins Verbal Learning Test-Revised, Spatial Span, Neuropsychological Assessment Battery Mazes, Brief Visuospatial Memory Test-Revised (BVMT-R), Category Fluency Test, Continuous Performance Test-Identical Pairs, and Mayer-Salovey-Caruso Emotional Intelligence Test-Managing Emotions. The MCCB evaluates seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Particular attention will be given to the visual learning domain assessed by BVMT-R, which measures visuospatial memory. Changes in MCCB composite T-score, domain-specific T-scores, and BVMT-R performance from baseline to week 4 will be analyzed.
Measured: Baseline and 4-week post-intervention
Change in Fixation Stability Eye Movement Metrics
Fixation stability tasks will be used to assess participants' ability to maintain stable visual fixation under simple and distracted conditions. Participants will be instructed to keep their gaze on a black dot (0.5° in size) presented at the center of the screen while ignoring peripheral distractor stimuli ("*" mark, 0.5° in size). During the first 5 seconds of each trial, only the central target will be presented (simple fixation condition). During the subsequent 5-10 seconds, distractor stimuli will appear randomly around the target (distracted fixation condition), with varying locations (left/right) and eccentricities (near/far). A total of 10 trials will be conducted. Eye movement data will be recorded throughout the task. Outcome measures will include fixation duration and saccade count, reflecting fixation stability and the ability to suppress involuntary eye movements.
Measured: Baseline and 4-week post-intervention
Change in Antisaccade Eye Movement Metrics
Antisaccade tasks will be used to assess oculomotor inhibitory control and executive regulation. Participants will first fixate on a central cross presented on a white screen. A peripheral target will then appear at different eccentricities, and participants will be instructed to suppress the reflexive saccade toward the target and generate a voluntary saccade toward the mirror position opposite to the target location. The task will include 30 antisaccade trials, with equal numbers of near- and far-target conditions. Outcome measures will include saccade latency, error rate, and saccade velocity, reflecting response initiation, inhibitory control, and oculomotor regulation.
Measured: Baseline and 4-week post-intervention
Change in Smooth Pursuit Eye Movement Metrics
Smooth pursuit tasks will be used to assess participants' ability to accurately track a moving visual target. Participants will be instructed to keep their heads motionless and follow a black dot presented on the screen using their eyes. The target will move according to predefined frequencies and trajectories. In the horizontal/vertical pursuit paradigm, the target will move horizontally and vertically with sinusoidal trajectories for 2.5 seconds each. In the Lissajous pursuit paradigm, the target will move simultaneously in horizontal and vertical directions using Lissajous trajectories with different frequencies and durations, including slow Lissajous pursuit (20 seconds) and fast Lissajous pursuit (10 seconds). Each trial will be repeated once. Outcome measures will include velocity gain, root mean square error (RMSE), and catch-up saccade count, reflecting pursuit accuracy, tracking precision, and compensatory eye movement responses.
Measured: Baseline and 4-week post-intervention
Change in Free-Viewing Eye-tracking Metrics
Free-viewing tasks will be used to assess visual exploration patterns and attentional allocation. Participants will be instructed to freely view 35 static images, including natural landscapes, social scenes, objects, and abstract patterns. Each image will be presented for 10 seconds, with participants maintaining fixation on a central cross between image presentations. Eye movement parameters will be extracted during image viewing. Outcome measures will include fixation count, fixation duration, scan path length, and mean pupil diameter, reflecting visual exploration strategies and attentional allocation.
Measured: Baseline and 4-week post-intervention
Secondary outcomes (2)
Change in Psychosis-Risk Symptom Severity (SOPS) Scores
Psychosis-risk symptom severity will be assessed using the Structured Interview for Psychosis-Risk Syndromes (SIPS), with symptom severity quantified using the Scale of Psychosis-Risk Symptoms (SOPS) in clinical high-risk participants. The SOPS consists of 19 items across four domains: positive symptoms, negative symptoms, disorganized symptoms, and general symptoms. Each item is rated on a 7-point scale (0-6), with higher scores indicating greater symptom severity. The total SOPS score ranges from 0 to 114. Changes in total and domain-specific SOPS scores from baseline to week 4 will be evaluated.
Measured: Baseline and 4-week post-intervention
Change in Positive and Negative Syndrome Scale (PANSS) Scores
Schizophrenia symptom severity will be assessed using the Positive and Negative Syndrome Scale (PANSS) in first-episode and chronic schizophrenia participants. The PANSS consists of 30 items grouped into three subscales: positive symptoms, negative symptoms, and general psychopathology. Each item is rated on a 7-point scale (1-7), with higher scores indicating greater symptom severity. The total PANSS score ranges from 30 to 210. Changes in total and subscale PANSS scores from baseline to week 4 will be evaluated.
Measured: Baseline and 4-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Model description
- Participants will be stratified by illness stage (clinical high-risk, first-episode schizophrenia, and chronic schizophrenia) and randomly assigned in a 1:1 ratio to either an eye-movement intervention group or an active control group. The study uses a parallel-group randomized controlled design with assessor blinding.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702526
- Sponsor's protocol ID
- ENI202606
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data (IPD) will not be publicly shared due to the sensitive nature of psychiatric clinical data, including participants with schizophrenia-spectrum disorders and individuals at clinical high risk for psychosis. The dataset contains detailed clinical, cognitive, and eye-tracking information that may increase the risk of re-identification. To protect participant confidentiality and comply with institutional ethics regulations, only aggregated results will be reported in publications.
Publications
Maldonado-Diaz M, Jara-Vargas G, Gonzalez-Seguel F. Visual attention during non-immersive virtual reality balance training in older adults with mild to moderate cognitive impairment: an eye-tracking study. Front Aging Neurosci. 2025 Oct 21;17:1671477. doi: 10.3389/fnagi.2025.1671477. eCollection 2025.
PubMed 41195081Kelly S, Guimond S, Lyall A, Stone WS, Shenton ME, Keshavan M, Seidman LJ. Neural correlates of cognitive deficits across developmental phases of schizophrenia. Neurobiol Dis. 2019 Nov;131:104353. doi: 10.1016/j.nbd.2018.12.013. Epub 2018 Dec 22.
PubMed 30582983Fett AJ, Reichenberg A, Velthorst E. Lifespan evolution of neurocognitive impairment in schizophrenia - A narrative review. Schizophr Res Cogn. 2022 Jan 20;28:100237. doi: 10.1016/j.scog.2022.100237. eCollection 2022 Jun.
PubMed 35242606Tschentscher N, Woll CFJ, Tafelmaier JC, Kriesche D, Bucher JC, Engel RR, Karch S. Neurocognitive Deficits in First-Episode and Chronic Psychotic Disorders: A Systematic Review from 2009 to 2022. Brain Sci. 2023 Feb 10;13(2):299. doi: 10.3390/brainsci13020299.
PubMed 36831842McCutcheon RA, Keefe RSE, McGuire PK. Cognitive impairment in schizophrenia: aetiology, pathophysiology, and treatment. Mol Psychiatry. 2023 May;28(5):1902-1918. doi: 10.1038/s41380-023-01949-9. Epub 2023 Jan 23.
PubMed 36690793Thakkar KN, Rolfs M. Disrupted Corollary Discharge in Schizophrenia: Evidence From the Oculomotor System. Biol Psychiatry Cogn Neurosci Neuroimaging. 2019 Sep;4(9):773-781. doi: 10.1016/j.bpsc.2019.03.009. Epub 2019 Apr 2.
PubMed 31105039Mitchell JP, Macrae CN, Gilchrist ID. Working memory and the suppression of reflexive saccades. J Cogn Neurosci. 2002 Jan 1;14(1):95-103. doi: 10.1162/089892902317205357.
PubMed 11798390Morita K, Miura K, Kasai K, Hashimoto R. Eye movement characteristics in schizophrenia: A recent update with clinical implications. Neuropsychopharmacol Rep. 2020 Mar;40(1):2-9. doi: 10.1002/npr2.12087. Epub 2019 Nov 27.
PubMed 31774633Wolf A, Ueda K, Hirano Y. Recent updates of eye movement abnormalities in patients with schizophrenia: A scoping review. Psychiatry Clin Neurosci. 2021 Mar;75(3):82-100. doi: 10.1111/pcn.13188. Epub 2021 Jan 20.
PubMed 33314465Dickinson D, Tenhula W, Morris S, Brown C, Peer J, Spencer K, Li L, Gold JM, Bellack AS. A randomized, controlled trial of computer-assisted cognitive remediation for schizophrenia. Am J Psychiatry. 2010 Feb;167(2):170-80. doi: 10.1176/appi.ajp.2009.09020264. Epub 2009 Dec 15.
PubMed 20008941Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.
PubMed 21406461Fioravanti M, Bianchi V, Cinti ME. Cognitive deficits in schizophrenia: an updated metanalysis of the scientific evidence. BMC Psychiatry. 2012 Jun 20;12:64. doi: 10.1186/1471-244X-12-64.
PubMed 22715980Shaikh MF, Higley C, Campanile C, Francis R, Panja E, Santacaterina S, Pratesi G, Piaggio D. Serious gaming and eye-tracking for the screening, monitoring, and diagnosis of neurodevelopmental disorders in children: a systematic literature review. Front Bioeng Biotechnol. 2026 Jan 14;13:1672718. doi: 10.3389/fbioe.2025.1672718. eCollection 2025.
PubMed 41613152Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.
PubMed 24005416Torous J, Bucci S, Bell IH, Kessing LV, Faurholt-Jepsen M, Whelan P, Carvalho AF, Keshavan M, Linardon J, Firth J. The growing field of digital psychiatry: current evidence and the future of apps, social media, chatbots, and virtual reality. World Psychiatry. 2021 Oct;20(3):318-335. doi: 10.1002/wps.20883.
PubMed 34505369
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Eye-Movement Intervention on Cognitive Impairment in Individuals Across Illness Stages of Schizophrenia: Protocol for a Stratified Randomized, Active-Controlled, Assessor-Blinded Trial
- ClinicalTrials.gov ID
- NCT07702526
- Acronym / sponsor ID
- ENI202606
- Keywords
- Eye movement training, Cognitive remediation, BVMT-R, Visuospatial memory, Eye tracking
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 14 Jul 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.
The goal of this clinical trial is to determine whether a gamified eye-movement intervention can improve cognitive function in individuals across the schizophrenia spectrum, including clinical high-risk individuals, first-episode schizophrenia patients, and chronic schizophrenia patients. The main questions it aims to answer are:
- Does eye-movement training improve cognitive performance measured by the MATRICS Consensus Cognitive Battery (MCCB)?
- Does eye-movement training improve oculomotor functions and clinical symptoms across different illness stages?
Researchers will compare an eye-movement intervention group with an active control group receiving matched finger-controlled game training to determine whether the eye-movement intervention produces greater improvements in cognitive function and eye-movement performance.
Participants will:
- Receive either gamified eye-movement training or matched finger-controlled game training for 4 weeks.
- Complete cognitive assessments using the MCCB before and after the intervention.
- Complete standardized eye-tracking tasks, including fixation stability, smooth pursuit, antisaccade, and free-viewing tasks, to evaluate changes in oculomotor control and visual exploration patterns.
- Complete clinical symptom assessments using SOPS or PANSS according to illness stage.
Detailed description
This study is a stratified, randomized, active-controlled, assessor-blinded clinical trial designed to evaluate the effects of a gamified eye-movement intervention on cognitive function across the schizophrenia spectrum, including clinical high-risk individuals, first-episode schizophrenia patients, chronic schizophrenia patients, and healthy controls.
Cognitive impairment is a core feature of schizophrenia-spectrum disorders and is associated with poor functional outcomes across illness stages. Eye movements are closely linked to cognitive processes such as attention, working memory, and executive control, suggesting that eye-movement-based training may have potential as a cognitive intervention.
Participants will be stratified by illness stage and randomly assigned in a 1:1 ratio to either an eye-movement intervention group or an active control group receiving matched finger-controlled game training. The intervention targets core oculomotor functions, including fixation control, smooth pursuit, and saccadic eye movements, through structured gamified training tasks. The intervention lasts 4 weeks, with 3-4 sessions per week.
The primary outcome is change in cognitive performance assessed using the MATRICS Consensus Cognitive Battery (MCCB), including composite and domain-specific T-scores from baseline to week 4. Secondary outcomes include changes in oculomotor functions and visual exploration patterns assessed using standardized eye-tracking tasks, including fixation stability, smooth pursuit, antisaccade, and free-viewing paradigms. Clinical symptom severity will be assessed using the Scale of Psychosis-Risk Symptoms (SOPS) for clinical high-risk participants and the Positive and Negative Syndrome Scale (PANSS) for schizophrenia participants.
Statistical analyses will evaluate intervention effects on cognitive, eye-movement, and clinical outcomes, including group-by-time interactions across illness stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be stratified by illness stage (clinical high-risk, first-episode schizophrenia, and chronic schizophrenia) and randomly assigned in a 1:1 ratio to either an eye-movement intervention group or an active control group. The study uses a parallel-group randomized controlled design with assessor blinding.
| Arm | Type | Receives |
|---|---|---|
| Eye-Movement Intervention Group | Experimental | Behavioral: Eye-Movement TrainingParticipants in this group will receive a gamified eye-movement intervention targeting fixation control, smooth pursuit, and saccadic eye movements. The training is delivered through interactive game-based tasks including fixation-based jumping, directional gaze control, and gaze-guided visual tracking. Participants will complete 3-4 sessions per week, with each session lasting approximately 30 minutes, for a total intervention period of 4 weeks. The intervention aims to improve visuospatial attention and cognitive performance. |
| Active Control Group (Finger-Controlled Game Training) | Active comparator | Behavioral: Finger-Controlled Game TrainingParticipants in this group will receive a finger-controlled gamified training program matched in duration, frequency, visual stimulation, and task structure to the experimental intervention. The training does not involve eye-movement control and serves as an active control condition to account for non-specific effects such as task engagement, visual exposure, and expectancy. Participants will complete 3-4 sessions per week, each lasting approximately 30 minutes, over a 4-week period. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Age between 15 and 45 years.
- More than 9 years of education.
- Normal or corrected-to-normal vision without color blindness, color weakness, strabismus, or nystagmus.
- Right-handedness.
- Impaired cognitive performance defined as a T-score <40 in at least one MCCB cognitive domain at baseline.
Key exclusion criteria (5 listed)
- IQ <70.
- Severe or unstable medical or neurological illness (e.g., stroke, epilepsy, dementia, cardiac disease, or uncontrolled hypertension).
- Substance abuse or dependence.
- Clinically significant laboratory abnormalities.
- Visual or auditory impairments affecting task performance.
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 |
|---|---|---|
| Eye-Movement TrainingA gamified eye-movement training program designed to improve fixation control, smooth pursuit, and saccadic eye movements. The intervention includes three interactive tasks: fixation-based jumping game, gaze-direction control game, and gaze-guided visual tracking game. Participants complete 3-4 sessions per week, approximately 30 minutes per session, for 4 weeks. The intervention is delivered via a computerized eye-tracking system. | Behavioural | Eye-Movement Intervention Group |
| Finger-Controlled Game TrainingA gamified finger-controlled training program matched in duration, frequency, visual stimulation, and task structure to the eye-movement intervention. Participants control game actions using finger inputs instead of eye movements. The intervention is designed as an active control to account for non-specific effects including engagement, visual exposure, and task expectancy. Participants complete 3-4 sessions per week, approximately 30 minutes per session, for 4 weeks. | Behavioural | Active Control Group (Finger-Controlled Game Training) |
Primary outcome
Change in MATRICS Consensus Cognitive Battery (MCCB) Scores
Time frame: Baseline and 4-week post-intervention
Cognitive function will be assessed using the MATRICS Consensus Cognitive Battery (MCCB), a standardized neurocognitive battery widely used in schizophrenia research. The MCCB consists of nine subtests, including Trail Making Test, Symbol Coding, Hopkins Verbal Learning Test-Revised, Spatial Span, Neuropsychological Assessment Battery Mazes, Brief Visuospatial Memory Test-Revised (BVMT-R), Category Fluency Test, Continuous Performance Test-Identical Pairs, and Mayer-Salovey-Caruso Emotional Intelligence Test-Managing Emotions. The MCCB evaluates seven cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. Particular attention will be given to the visual learning domain assessed by BVMT-R, which measures visuospatial memory. Changes in MCCB composite T-score, domain-specific T-scores, and BVMT-R performance from baseline to week 4 will be analyzed.
Change in Fixation Stability Eye Movement Metrics
Time frame: Baseline and 4-week post-intervention
Fixation stability tasks will be used to assess participants' ability to maintain stable visual fixation under simple and distracted conditions. Participants will be instructed to keep their gaze on a black dot (0.5° in size) presented at the center of the screen while ignoring peripheral distractor stimuli ("*" mark, 0.5° in size). During the first 5 seconds of each trial, only the central target will be presented (simple fixation condition). During the subsequent 5-10 seconds, distractor stimuli will appear randomly around the target (distracted fixation condition), with varying locations (left/right) and eccentricities (near/far). A total of 10 trials will be conducted. Eye movement data will be recorded throughout the task. Outcome measures will include fixation duration and saccade count, reflecting fixation stability and the ability to suppress involuntary eye movements.
Change in Antisaccade Eye Movement Metrics
Time frame: Baseline and 4-week post-intervention
Antisaccade tasks will be used to assess oculomotor inhibitory control and executive regulation. Participants will first fixate on a central cross presented on a white screen. A peripheral target will then appear at different eccentricities, and participants will be instructed to suppress the reflexive saccade toward the target and generate a voluntary saccade toward the mirror position opposite to the target location. The task will include 30 antisaccade trials, with equal numbers of near- and far-target conditions. Outcome measures will include saccade latency, error rate, and saccade velocity, reflecting response initiation, inhibitory control, and oculomotor regulation.
Change in Smooth Pursuit Eye Movement Metrics
Time frame: Baseline and 4-week post-intervention
Smooth pursuit tasks will be used to assess participants' ability to accurately track a moving visual target. Participants will be instructed to keep their heads motionless and follow a black dot presented on the screen using their eyes. The target will move according to predefined frequencies and trajectories. In the horizontal/vertical pursuit paradigm, the target will move horizontally and vertically with sinusoidal trajectories for 2.5 seconds each. In the Lissajous pursuit paradigm, the target will move simultaneously in horizontal and vertical directions using Lissajous trajectories with different frequencies and durations, including slow Lissajous pursuit (20 seconds) and fast Lissajous pursuit (10 seconds). Each trial will be repeated once. Outcome measures will include velocity gain, root mean square error (RMSE), and catch-up saccade count, reflecting pursuit accuracy, tracking precision, and compensatory eye movement responses.
Change in Free-Viewing Eye-tracking Metrics
Time frame: Baseline and 4-week post-intervention
Free-viewing tasks will be used to assess visual exploration patterns and attentional allocation. Participants will be instructed to freely view 35 static images, including natural landscapes, social scenes, objects, and abstract patterns. Each image will be presented for 10 seconds, with participants maintaining fixation on a central cross between image presentations. Eye movement parameters will be extracted during image viewing. Outcome measures will include fixation count, fixation duration, scan path length, and mean pupil diameter, reflecting visual exploration strategies and attentional allocation.
2 secondary outcomes
Change in Psychosis-Risk Symptom Severity (SOPS) Scores
Time frame: Baseline and 4-week post-intervention
Change in Positive and Negative Syndrome Scale (PANSS) Scores
Time frame: Baseline and 4-week post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Background: PubMed 41195081Maldonado-Diaz M, Jara-Vargas G, Gonzalez-Seguel F. Visual attention during non-immersive virtual reality balance training in older adults with mild to moderate cognitive impairment: an eye-tracking study. Front Aging Neurosci. 2025 Oct 21;17:1671477. doi: 10.3389/fnagi.2025.1671477. eCollection 2025.
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- Individual participant dataSharing planned: No. De-identified individual participant data (IPD) will not be publicly shared due to the sensitive nature of psychiatric clinical data, including participants with schizophrenia-spectrum disorders and individuals at clinical high risk for psychosis. The dataset contains detailed clinical, cognitive, and eye-tracking information that may increase the risk of re-identification. To protect participant confidentiality and comply with institutional ethics regulations, only aggregated results will be reported in publications.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-Movement Training in people with Schizophrenia and Cognitive Impairment, run by Shanghai Mental Health Center.
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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tianhong Zhang, MD (86-21-3477 3065, zhang_tianhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MATRICS Consensus Cognitive Battery (MCCB) Scores (time frame: Baseline and 4-week post-intervention). The study lists 5 primary outcomes in all. 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 NCT07702526, which also lists 17 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 14 Jul 2026.