VRiS: Remediation of Visual Perceptual Impairments in Schizophrenia

Sponsor
University of Rochester (Other)
Overall Status
Recruiting
CT.gov ID
NCT03314129
Collaborator
New York University (Other)
180
2
4
87
90
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: UltimEyes
  • Behavioral: Contour Integration Training
  • Behavioral: UltimEyes + Contour Integration Training
  • Behavioral: MyBrainSolutions
N/A

Detailed Description

It is increasingly clear that people with schizophrenia have a range of visual perception impairments, including in low-level vision (e.g., acuity, contrast sensitivity) and mid-level vision (e.g., perceptual organization, coherent motion detection). These impairments are significantly related to poorer performance on cognitive (e.g., visual learning and memory) and social cognitive (e.g., facial emotion decoding) measures, and to worse functional outcomes. To date, there is no accepted technique for visual remediation for schizophrenia, and almost no work has been done in this area. However, visual remediation is a well-developed subfield within cognitive rehabilitation for traumatic brain injury (TBI) patients, and initial studies of short-term visual perceptual learning in schizophrenia indicate that plasticity exists that could support longer-term changes. Therefore, the overall goal of the proposed project is to test a visual remediation intervention for schizophrenia and determine its effects on specific visual targets with well-understood neurobiological mechanisms. The goal of the R61 is to determine the optimal intervention for improving the targets of contrast sensitivity (CS) and perceptual organization (PO). Extensive evidence exists for impaired CS and PO in schizophrenia. Moreover, these targets are prototypical examples of gain control and integration, respectively, which were identified by the NIMH-sponsored CNTRICS initiative as being the two core mechanisms involved in visual disturbances in the disorder. The investigators will examine two computer-based interventions. One, ULTIMEYES (UE), targets CS. The other, contour integration training (CIT), targets PO. The investigators will also examine the effects of combined treatment (UE&CIT). An active computer-based control treatment will be included. There will be 40 sessions, with assessments after every 10 sessions (N=20/group). The R61 Specific Aim is to evaluate the effects of UE and CIT on CS and PO targets, respectively, to determine if treatment effects meet a pre-specified effect-size criterion. Results of the R61 will be used to identify the treatment (UE, CIT, or UE&CIT) and duration (i.e., dose) that most effectively and efficiently improves the target(s). The goal of the R33 is to conduct an initial randomized controlled trial (RCT) of the optimal treatment identified in the R61. The R33 Specific Aims are to: 1) replicate and extend R61 results supporting visual target engagement in an adequately powered RCT (N=50/group); and 2) determine if visual target engagement is associated with improvements in cognition, social cognition, and functional capacity. If the R33 hypotheses are confirmed, results will inform the design of a later RCT to further explore mediators and moderators of treatment effects, and to move towards a precision medicine approach, wherein we determine which individuals are most likely to benefit from this intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Visual Remediation in Schizophrenia
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
May 31, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Contrast sensitivity

UltimEyes

Behavioral: UltimEyes
A computer program developed to improve contrast sensitivity and visual acuity.

Experimental: Perceptual organization

Contour Integration Training

Behavioral: Contour Integration Training
A computerized program to improve contour integration (a form of perceptual organization).

Experimental: Contrast sensitivity + Perceptual org.

UltimEyes + Contour Integration Training

Behavioral: UltimEyes + Contour Integration Training
The combination of UltimEyes and Contour Integration Training

Active Comparator: Cognitive remediation

MyBrainSolutions

Behavioral: MyBrainSolutions
A computer program consisting of exercises to improve cognition (attention, memory, planning) and to facilitate goal setting.

Outcome Measures

Primary Outcome Measures

  1. Contrast sensitivity - behavioral [Years 1-5]

    Peak contrast, as measures by a behavioral (psychophysical) measure of contrast sensitivity.

  2. Contrast sensitivity - electrophysiological [Years 1-5]

    Steady state visual evoked potential (ssVEP) amplitudes recorded during the contrast sensitivity task.

  3. Contour integration [Years 1-5]

    Total score on the Jittered-Orientation Visual Integration Task, or JOVI), a psychophysical measure of perceptual organization.

Secondary Outcome Measures

  1. Reading speed [Years 3-5]

    Minnesota Low-Vision Reading Test (MNREAD): This test assesses reading speed ability. The charts contain 19 English sentences (60 characters each) with print sizes ranging from 1.3 to -0.5 logMAR at a distance of 16 inches (0.41 meters).

  2. Emotion recognition [Years 3-5]

    Total score on the Penn Emotion Recognition Test, a computerized test of emotion recognition.

  3. Cognition [Years 3-5]

    Total score on the MATRICS Consensus Cognitive Battery

  4. Community functioning [Years 3-5]

    Total score on the UCSD Performance-Based Skills Assessment (UPSA), a test of the ability to perform various skills important in residential and community settings.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. SCID-5 diagnosis of schizophrenia;

  2. 18-60 years old;

  3. speaks English;

  4. able to complete the MATRICS Consensus Cognitive Battery (MCCB) at the baseline assessment (for R33);

  5. 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; and

  6. clinically stable as indicated by no antipsychotic medication changes in the last month or if on depot, no change in the past 2 months.

Exclusion Criteria:
  1. history of intellectual disability, or developmental or neurological disorder;

  2. history of brain trauma associated with loss of consciousness for > 10 minutes or behavioral sequelae;

  3. alcohol or substance use disorder within the last 6 months; and

  4. history of eye disease (e.g., glaucoma, retinopathy).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Rochester Medical Center - Strong Ties Community Support Clinic Rochester New York United States 14623
2 New York Presbyterian Hospital White Plains New York United States 10605

Sponsors and Collaborators

  • University of Rochester
  • New York University

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Steven Silverstein, Professor, University of Rochester
ClinicalTrials.gov Identifier:
NCT03314129
Other Study ID Numbers:
  • 20170000922
  • U.S. NIH Grant # 1R61MH115119
First Posted:
Oct 19, 2017
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022