Eye-Movement Intervention for Cognitive Impairment Across Schizophrenia Spectrum

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-45
SponsorShanghai Mental Health Center

About this 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?

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Eye-Movement Intervention GroupExperimental treatment 1 intervention
Group B: Active Control Group (Finger-Controlled Game Training)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 4-week post-intervention
2

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.

Time frame
Baseline and 4-week post-intervention
3

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.

Time frame
Baseline and 4-week post-intervention
4

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.

Time frame
Baseline and 4-week post-intervention

Secondary outcomes

1

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.

Time frame
Baseline and 4-week post-intervention
2

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.

Time frame
Baseline and 4-week post-intervention

Other outcomes

Locations

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