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 — BEHAVIORAL
    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 Training — BEHAVIORAL
    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 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 Group
    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.
  • 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

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