NCT01959256

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable stroke

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

4.3 years

First QC Date

October 7, 2013

Last Update Submit

January 14, 2019

Conditions

StrokeVisual Field Defect

Keywords

StrokeVisual Field DefectVisual perceptual learningBrain connectivity

Outcome Measures

Primary Outcomes (1)

  • 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 (5)

  • Performance of visual perceptual learning

    At 2 months (plus or minus 7 days) after baseline evaulation

  • Connectivity changes in MRI

    Between baseline and 2 months (plus or minus 7 days) after

  • Improvement of visual field score in whole visual field area

    At 2 months (plus or minus 7days) after baseline evaluation

  • Change of subjective visual function

    At 2 months (plus or minus 7days) after baseline evaluation

  • Changes of visual evoked potential

    Between baseline and 2 months (plus or minus 7 days) after

Study Arms (2)

Learning

EXPERIMENTAL

Visual perceptual learning (VPL) group

Behavioral: Visual perceptual learning

Control

NO INTERVENTION

Control group

Interventions

Visual perceptual learningBEHAVIORAL

24 times of training for visual perceptual learning

Learning

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dong-Wha Kang, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations

KR(1)