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Peripheral Vision Training Study (PVTS)

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ClinicalTrials.gov Identifier: NCT03141164
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Kristina M Visscher, University of Alabama at Birmingham

Brief Summary:
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.

Condition or disease Intervention/treatment Phase
Visual Impairment Cognitive Change Other: computerized training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Computerized training for all groups. This is a pilot study.
Primary Purpose: Basic Science
Official Title: Peripheral Vision Training Study
Actual Study Start Date : May 30, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2020

Arm Intervention/treatment
Experimental: Training
Computerized vision training
Other: computerized training
Computerized training

Sham Comparator: Control
Sham
Other: computerized training
Computerized training




Primary Outcome Measures :
  1. Improvement in scores on acuity tests [ Time Frame: baseline and immediately following training ]
    Improvement in scores on acuity tests

  2. Improvement in scores on spatial attention tests [ Time Frame: baseline and immediately following training ]
    Improvement in scores on spatial attention tests


Secondary Outcome Measures :
  1. Changes in cortical thickness [ Time Frame: baseline and immediately following training ]
    Increases in cortical thickness in areas corresponding to trained visual field

  2. Changes in functional connectivity [ Time Frame: baseline and immediately following training ]
    Changes in functional connectivity of areas corresponding to trained visual field



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Right handed individuals
  • Aged 19-89
  • In good health as self-reported or visual impairments due to partial vision loss
  • Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss

Exclusion criteria:

  • Younger than 18 or older than 89
  • Being hearing-impaired
  • Not in good health except due to partial vision loss
  • Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
  • Having hallucinations or delusions
  • Having a current or past history of a substance abuse disorder
  • Currently taking psychoactive medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141164


Locations
United States, Alabama
UAB Recruiting
Birmingham, Alabama, United States, 35294
Contact: Kristina Visscher    205-934-0267    kmv@uab.edu   
Principal Investigator: Kristina M Visscher, Ph.D.         
Sponsors and Collaborators
University of Alabama at Birmingham

Responsible Party: Kristina M Visscher, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03141164     History of Changes
Other Study ID Numbers: X101022014
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Vision Disorders
Vision, Low
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms