Visual Perceptual Learning for the Treatment of Visual Fi... | NCT01959256

Studies
Visual Perceptual Learning for the Treatment of Visual Field Defect

NCT01959256

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Jan 16, 2019Actual

Enrollment

36Actual

Phase

Not Applicable

Conditions

Stroke
Visual Field Defect

Interventions

Visual perceptual learning

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2018Actual

First Submitted Date

Oct 7, 2013

First Submission Date that Met QC Criteria

Oct 8, 2013

First Posted Date

Oct 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2019

Last Update Posted Date

Jan 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong-Wha Kang, MD, PhD, Asan Medical CenterPrincipal Investigator

Lead Sponsor

Asan Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will test the hypothesis whether visual field defect caused by chronic stroke could be improved by visual perceptual learning. The secondary hypothesis is that improvement of visual field defect would be accompanied by connectivity changes in visual networks. In addition, investigators will evaluate whether improvement of visual field defect could achieve improvement of subjective visual function.

Detailed Description

Study design: A PROBE (Prospective, Randomized, Open-label, Blinded-endpoint) design

Methods:

Visual perceptual learning (VPL) group
1. Visual perceptual learning (24 times for 2 months, 3 times per week) in visual field defect areas
2. At baseline and post-VPL evaluations (2 months after): Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
Control group
1. At baseline and 2-months later: No VPL, Structural & Functional MRIs, Visual field tests, Visual evoked potential, Visual cognitive tests, Subjective visual function questionnaires
2. Visual perceptual learning after 2-month follow-up evaluation (24 times for 2 months, 3 times per week)
(The patients who were stratified by age (over 65 years old or not) and degree of visual field defect (quadrantanopia or complete hemianopia) will be randomly assigned into the learning and control group.)
Investigations
1. Improvement of visual field test scores between VPL group and control group
2. Analysis of brain network changes in MRI data
3. Correlation analysis of improvement of visual field defect and MRI data
4. Correlation analysis of improvement of visual field defect and visual evoked potential (VEP) data
5. Correlation analysis of improvement of visual field defect and neuropsychological data

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Learning	Experimental	Visual perceptual learning (VPL) group	Behavioral: Visual perceptual learning
Control	No Intervention	Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Visual perceptual learning	Behavioral	24 times of training for visual perceptual learning	Learning

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement of visual field scores in visual field defect areas	Improvement of mean deviation scores in defected areas by Humphrey 750i Field test	At 2 months (plus or minus 7 days) after baseline evaluation

Secondary Outcomes

Measure	Description	Time Frame
Performance of visual perceptual learning	Performance (scores) of visual perceptual learning	At 2 months (plus or minus 7 days) after baseline evaulation
Connectivity changes in MRI	Functional connectivity changes in resting-state functional MRI Structural connectivity changes in diffusion tensor imaging

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patient has chronic stroke more than 6 months after onset.
The patient has visual field defect (Quadrantanopia or Hemianopia).
The patient has corrected eyesight 0.7 or above.

Exclusion Criteria:

The patient has contraindication to MRI scan.
The patient has cognitive impairment (Mini-Mental Status Exam score <24).
The patient has ophthalmologic diseases (e.g., glaucoma, cataract).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong-Wha Kang, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided