Visual Perceptual Remediation for Schizophrenia

(VRiS Trial)

Recruiting at 1 trial location

Overseen By Pamela Butler, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Must be taking: Antipsychotics

Disqualifiers: Intellectual disability, Neurological disorder, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

79 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two visual functions that much research has shown are impaired in many people with the disorder, namely contrast sensitivity and perceptual organization. The first phase of the study will test the effects of interventions targeting each of these processes, as well as the effects of a combined package. A control condition of higher-level cognitive remediation is included as a fourth condition. The second phase of the study will evaluate the effectiveness of the most effective intervention from the first phase, but in a new and larger sample of individuals. Outcome measures include multiple aspects of visual functioning, as well as visual cognition and overall community functioning.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be clinically stable, meaning no changes in your antipsychotic medication in the last month or two, depending on the type.

What data supports the effectiveness of the treatment Contour Integration Training, MyBrainSolutions, UltimEyes, and UltimEyes + Contour Integration Training for schizophrenia?

Research shows that cognitive training, which includes computer-based visual exercises, can improve visual learning and memory in people with schizophrenia. These improvements are linked to changes in brain function, suggesting that such treatments can help enhance cognitive abilities in patients. ^{1 2 3 4 5}

Is visual perceptual remediation safe for humans?

The research does not provide specific safety data for visual perceptual remediation, but it suggests that cognitive training methods, including visual tasks, are generally feasible and have been used in schizophrenia without reported safety concerns. ^{2 4 6 7 8}

How does the treatment 'Visual Perceptual Remediation for Schizophrenia' differ from other treatments for schizophrenia?

This treatment is unique because it focuses on improving visual perception through Contour Integration Training and UltimEyes, which aim to enhance the brain's ability to process visual information, a common challenge in schizophrenia. Unlike traditional treatments that primarily target symptoms like hallucinations and delusions, this approach addresses the underlying visual processing deficits. ^{9 10 11 12 13}

Research Team

Steven M Silverstein, Ph.D.

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for individuals aged 18-60 with a diagnosis of schizophrenia, who speak English and can complete basic cognitive tests. They should be clinically stable with no recent medication changes and have at least a 6th-grade reading level. People with eye diseases, recent substance abuse, intellectual disabilities, or significant brain trauma are not eligible.

Inclusion Criteria

A raw score of 37 or greater on the Wide Range Achievement Test, Reading subtest (WRAT-3), to establish a minimum reading level (6th grade) and to estimate premorbid IQ

I have been diagnosed with schizophrenia.

My antipsychotic medication has not changed in the last month.

Exclusion Criteria

Alcohol or substance use disorder within the last 6 months

History of intellectual disability, or developmental or neurological disorder

I have had a head injury that made me unconscious for more than 10 minutes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants undergo interventions targeting contrast sensitivity and perceptual organization, including ULTIMEYES and Contour Integration Training, with assessments after every 10 sessions

40 sessions

Assessments after every 10 sessions

Phase 2 Treatment

Randomized controlled trial of the optimal treatment identified in Phase 1, with a focus on visual target engagement and associated improvements

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, with outcome measures including visual functioning, cognition, and community functioning

Years 1-5

Treatment Details

Interventions

• Contour Integration Training
• MyBrainSolutions
• UltimEyes
• UltimEyes + Contour Integration Training

Trial Overview The study evaluates the effectiveness of visual remediation interventions for schizophrenia patients. It examines contrast sensitivity and perceptual organization through UltimEyes + Contour Integration Training versus each method alone or MyBrainSolutions as control. The best approach from phase one will undergo further testing in phase two.

Participant Groups

Group I: Perceptual organization Experimental Treatment 1 Intervention

Contour Integration Training

Group II: Contrast sensitivity + Perceptual org. Experimental Treatment 1 Intervention

UltimEyes + Contour Integration Training

Group III: Contrast sensitivity Experimental Treatment 1 Intervention

UltimEyes

Group IV: Cognitive remediation Active Control 1 Intervention

MyBrainSolutions

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Findings from Research

Cognitive remediation strategies for schizophrenia have shown improvements in working memory, emotion perception, and executive function, indicating that targeted cognitive exercises can effectively engage underfunctioning brain systems.

Cognitive adaptation interventions have been linked to better symptoms, psychosocial status, and reduced relapse rates, suggesting that modifying the environment can help patients manage their cognitive deficits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive rehabilitation for schizophrenia. Kurtz, MM.[2019]

A meta-analysis of over a decade of cognitive remediation research has identified key factors for effective cognitive training in schizophrenia, such as computerized practice, high dosing schedules, and individualized learning trials.

A preliminary randomized controlled trial showed that cognitive training based on these principles led to significant improvements in working memory and global cognition in patients with schizophrenia, along with evidence of cortical plasticity in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training in schizophrenia: a neuroscience-based approach. Genevsky, A., Garrett, CT., Alexander, PP., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Neurocognitive rehabilitation for schizophrenia. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive training in schizophrenia: a neuroscience-based approach. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Successful computer-based visual training specifically predicts visual memory enhancement over verbal memory improvement in schizophrenia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Neuroscience-informed computer-assisted cognitive training in schizophrenia. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Targeted cognitive training improves auditory and verbal outcomes among treatment refractory schizophrenia patients mandated to residential care. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of attention training in schizophrenia. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Visual perceptual remediation for individuals with schizophrenia: Rationale, method, and three case studies. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Perception measurement in clinical trials of schizophrenia: promising paradigms from CNTRICS. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

The spatial range of contour integration deficits in schizophrenia. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Contour integration impairment in schizophrenia and first episode psychosis: state or trait? [2021]

11. England pubmed.ncbi.nlm.nih.gov

Cortical contributions to impaired contour integration in schizophrenia. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Reduced crowding and poor contour detection in schizophrenia are consistent with weak surround inhibition. [2023]

13. Singapore pubmed.ncbi.nlm.nih.gov

An fMRI examination of visual integration in schizophrenia. [2019]