NCT03141164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 8, 2021

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

April 28, 2017

Last Update Submit

June 4, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Changes in cortical thickness

    baseline and immediately following training

  • Changes in functional connectivity

    baseline and immediately following training

Study Arms (2)

Training

EXPERIMENTAL

Computerized vision training

Other: computerized training

Control

SHAM COMPARATOR

Sham

Other: computerized training

Interventions

Computerized training

ControlTraining

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Computerized training for all groups. This is a pilot study.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 4, 2017

Study Start

May 30, 2017

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

June 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations