Visual Perceptual Remediation for Schizophrenia

(VRiS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new visual training program for people with schizophrenia, aiming to improve how they see and organize visual information. Participants are divided into groups to try various exercise combinations, including one that combines two types of visual training (UltimEyes and Contour Integration Training) and another that focuses on general cognitive skills. The researchers aim to determine which method most effectively improves visual and community functioning. This trial suits those diagnosed with schizophrenia who haven't recently changed their medication and don't have an eye disease. As an unphased trial, participants can contribute to innovative research that could enhance treatment options for schizophrenia.

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 prior data suggests that this visual remediation intervention is safe for people with schizophrenia?

Research has shown that the safety of visual perceptual treatments like UltimEyes and Contour Integration Training isn't well-documented in existing studies. However, these treatments use non-invasive methods to enhance the brain's processing of visual information, making physical side effects less likely.

For UltimEyes, no specific reports of negative effects have emerged from its use in improving the brain's handling of visual inputs. Contour Integration Training aids the brain in organizing visual information more effectively. Although detailed safety data remains limited, this method is generally considered low-risk due to its non-invasive nature.

Since these treatments work by training the brain through visual exercises, they are less likely to cause harm. It is important to note that research on these treatments is ongoing, and participants will be closely monitored for any unexpected reactions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for schizophrenia because they offer new ways to enhance visual processing, which is often impaired in this condition. Contour Integration Training focuses on improving how patients perceive visual patterns, potentially enhancing their overall cognitive function. UltimEyes is a digital tool designed to boost contrast sensitivity, which can help patients better interpret visual information. The combination of UltimEyes and Contour Integration Training aims to maximize these benefits, providing a comprehensive approach to visual and cognitive remediation not typically addressed by standard antipsychotic medications. These innovative strategies could complement existing treatments by targeting the sensory and perceptual difficulties that are not usually the main focus of current therapies.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

Studies have shown that specific training methods can improve visual perception problems in people with schizophrenia. In this trial, participants may receive UltimEyes, a program that enhances contrast sensitivity and has demonstrated significant positive effects on visual processing. Another group will receive Contour Integration Training, which research indicates can quickly improve shape and pattern recognition. Additionally, some participants will receive a combination of UltimEyes and Contour Integration Training to enhance both contrast sensitivity and the ability to organize visual information, potentially leading to better overall visual functions. Although researchers are still studying these methods, early results suggest they could greatly enhance visual thinking and everyday functioning for people with schizophrenia. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven M Silverstein, Ph.D.

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

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The purpose of this study is to evaluate the effectiveness of a visual remediation intervention for people with schizophrenia. The intervention targets two ...

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Impaired contour object perception in psychosis - PMC

Our results are consistent with impaired contour integration in psychotic psychopathology, and especially schizophrenia, that is related to cognitive ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3466169/

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Contour integration (CI) refers to the process that represents spatially separated elements as a unified edge or closed shape. Schizophrenia is a ...

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nature.com

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withpower.com

withpower.com/trial/phase-psychotic-disorders-11-2018-d68c0

Visual Perceptual Remediation for Schizophrenia (VRiS Trial)

Is visual perceptual remediation safe for humans? The research does not provide specific safety data for visual perceptual remediation, but it suggests that ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0920996421001791

Going deep into schizophrenia with artificial intelligence

Deep learning research in schizophrenia. In this section, we review deep learning applications for diagnosis (classification) and outcome prediction in the ...