NCT01062672

Brief Summary

The study's objective is to measure changes in human visual cortex organization that may arise as a result of injury to the visual pathways. Subjects with retinal or cortical injury will be studied and compared to appropriate controls. Functional magnetic resonance imaging methods are used to monitor cortical topography in time. The main aims of the study are to determine: 1) what are the patterns of cortical reorganization that are seen spontaneously after injury, and 2) whether rehabilitative training can promote adaptive reorganization enhancing recovery.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
withdrawn

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

January 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

6.9 years

First QC Date

February 3, 2010

Last Update Submit

April 1, 2022

Conditions

Keywords

plasticityreorganizationcorticalfMRIrehabilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lesions of the visual pathway (cortical or retinal)

You may qualify if:

  • Stable lesion of the visual pathways resulting in a visual field scotoma.

You may not qualify if:

  • Inability to undergo magnetic resonance imaging,
  • Inability to comply with basic instructions,
  • Inability to perform the behavioral tasks required,
  • Patients with chronic progressive neurological or psychiatric disorders,
  • Patients that are pregnant, or breast feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Max Planck Institute for Biological Cybernetics

Tübingen, Germany

Location

MeSH Terms

Conditions

StrokeBlindness

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 3, 2010

First Posted

February 4, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 11, 2022

Record last verified: 2022-04

Locations