Eye-Movement Intervention for Cognitive Impairment Across Schizophrenia Spectrum
- Sponsor
- Shanghai Mental Health Center
- Study ID
- NCT07702526
- Status
- Not Yet Recruiting
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Conditions
- Clinical High Risk for Psychosis
- Cognitive Impairment
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 45 Years
- Healthy Volunteers
- Accepted
Interventions
- Eye-Movement Training — BEHAVIORALA 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 Training — BEHAVIORALA 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 Details
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.
Key Dates
- First listed
- Jul 14, 2026
- Start date
- Jul 1, 2026
- Status verified
- Jun 2026
- Primary completion
- Dec 30, 2027
- Completion
- Jul 30, 2028
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Eye-Movement Intervention GroupParticipants 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 Comparator: Active Control Group (Finger-Controlled Game Training)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.
Primary Outcome Measure
Change in MATRICS Consensus Cognitive Battery (MCCB) Scores [ Time Frame: Baseline and 4-week post-intervention ]
Central Contacts
- Tianhong Zhang, MD86-21-3477 3065
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