Skip to main content
Clinical Trials/NCT04798924
NCT04798924
Active, not recruiting
Not Applicable

Visual Rehabilitation After Occipital Stroke

University of Rochester1 site in 1 country60 target enrollmentJuly 19, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
University of Rochester
Enrollment
60
Locations
1
Primary Endpoint
Direction Discrimination Threshold
Status
Active, not recruiting
Last Updated
5 months ago

Overview

Brief Summary

This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.

Registry
clinicaltrials.gov
Start Date
July 19, 2021
End Date
January 1, 2028
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Krystel Huxlin

James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology

University of Rochester

Eligibility Criteria

Inclusion Criteria

  • Residents of US and Canada
  • MRI and/or CT scans showing evidence of one-sided / unilateral stroke or stroke-like damage to the primary visual cortex or its immediate afferent white matter sustained less than 6-months prior to enrollment
  • Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
  • Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
  • Willing and safely able to undergo magnetic resonance imaging (MRI) scanning
  • Willing, able, and competent to provide informed consent
  • Fluent in written and spoken English
  • Cognitively able, responsible, and willing to complete daily visual training independently at home for several months.

Exclusion Criteria

  • Past or present ocular disease interfering with vision
  • Best corrected visual acuity worse than 20/40 in either eye
  • Presence of damage to the dorsal Lateral Geniculate Nucleus, as shown on MRI/CT scans
  • Diffuse, whole brain degenerative processes
  • Brain damage deemed by study staff to potentially interfere with training ability or outcome measures
  • History of traumatic brain injury
  • Documented history of drug/alcohol abuse
  • Currently use of neuroactive medications which would impact training, as determined by PI
  • Cognitive or seizure disorders
  • One-sided attentional neglect

Outcomes

Primary Outcomes

Direction Discrimination Threshold

Time Frame: baseline, 6 months, 12 months

For each subject, we will measure the ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.\*\* \*\*NOTE: Our protocol allows for a +1 month variance for all timepoints.

Secondary Outcomes

  • Direction Integration Threshold(baseline, 6 months, 12 months)
  • Ganglion cell complex volume laterality(baseline, 6 months, 12 months)
  • contrast sensitivity for static orientation(baseline, 6 months, 12 months)
  • Optic Tract (OT) laterality(baseline, 6 months, 12 months)
  • Ganglion cell complex thickness laterality(baseline, 6 months, 12 months)
  • Contrast Sensitivity for Direction(baseline, 6 months, 12 months)

Study Sites (1)

Loading locations...

Similar Trials