Peripheral Vision Training Study (PVTS)

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Visual Impairment
• Intervention / Treatment: Other: computerized training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Training; Computerized vision training	Other: computerized training; Computerized training
SHAM_COMPARATOR: Control; Sham	Other: computerized training; Computerized training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scores on acuity tests	scores on acuity tests	baseline
scores on acuity tests	scores on acuity tests	immediately following training
scores on spatial attention tests	scores on spatial attention tests	baseline
scores on spatial attention tests	scores on spatial attention tests	immediately following training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cortical thickness	Increases in cortical thickness in areas corresponding to trained visual field	baseline and immediately following training
Changes in functional connectivity	Changes in functional connectivity of areas corresponding to trained visual field	baseline and immediately following training

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2017
• Primary Completion (ACTUAL): September 30, 2020
• Study Completion (ACTUAL): September 30, 2020

Study Registration Dates

• First Submitted: April 28, 2017
• First Submitted That Met QC Criteria: May 3, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision, Low; Vision Disorders
• Other Study ID Numbers: X101022014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No