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Visual Rehabilitation After Occipital Stroke

Primary Purpose

Stroke, Ischemic, Quadrantanopia, Vision Loss Partial

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Subacute Training in the intact field
Subacute Training in the blind field
Chronic Training in the blind field
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Occipital stroke, vision loss, Homonymous quadrantanopia, Homonymous quadrantanopsia, stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Residents of US and Canada
  • MRI and/or CT scans showing evidence of 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
  • Inability to perform the visual training exercises as directed

Sites / Locations

  • University of RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Training in the blind field

Training in the intact field

Arm Description

Training in the blind field using specialized software

Training in the intact field using specialized software

Outcomes

Primary Outcome Measures

Direction Discrimination Threshold
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 Outcome Measures

Direction Integration Threshold
This will measure the ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated 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.
Contrast Sensitivity for Direction
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. For each subject, we will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that 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.
contrast sensitivity for static orientation
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. For each subject, we will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that 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.
Ganglion cell complex thickness laterality
Change in thickness of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.** We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated thickness of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index LI as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant. **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Ganglion cell complex volume laterality
Change in volume of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.** We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated volume of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant. **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Optic Tract (OT) laterality
OT volume analysis will be performed from high resolution structural T1 MRI images of the brain. Mirrored masks of equal size will be hand-drawn over the OTs in each brain slice of a given subject, starting three slices posterior to the optic chiasm and continuing posteriorly until the OTs are no longer distinct from surrounding structures. The volume of each optic tract will be calculated from these masks by first establishing the maximum voxel intensity (range from 0 to 255) across the two OTs, then counting the number of voxels in each OT mask with brightness values between 5 and 85% of this maximum. We will then compute an OT laterality Index (LI85) to represent the relative difference in estimated volume between the two OTs of each participant, where LI85=(OTc-OTi)/(OTc+OTi), where OTc=number of voxels with brightness 5-85% of maximum in the contralesional OT and OTi = number of voxels with brightness 5-85% of maximum in the ipsilesional OT.

Full Information

First Posted
February 25, 2021
Last Updated
August 16, 2023
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04798924
Brief Title
Visual Rehabilitation After Occipital Stroke
Official Title
Visual Rehabilitation After Occipital Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
March 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Quadrantanopia, Vision Loss Partial, Visual Field Defect, Peripheral, Peripheral Visual Field Defect of Both Eyes, Peripheral Visual Field Defect, Hemianopsia, Hemianopia, Homonymous Hemianopia, Homonymous Hemianopsia, Visual Fields Hemianopsia, Occipital Lobe Infarct, Quadrantanopsia, Stroke Hemorrhagic
Keywords
Occipital stroke, vision loss, Homonymous quadrantanopia, Homonymous quadrantanopsia, stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training in the blind field
Arm Type
Experimental
Arm Description
Training in the blind field using specialized software
Arm Title
Training in the intact field
Arm Type
Experimental
Arm Description
Training in the intact field using specialized software
Intervention Type
Device
Intervention Name(s)
Subacute Training in the intact field
Intervention Description
A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the intact field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.
Intervention Type
Device
Intervention Name(s)
Subacute Training in the blind field
Intervention Description
A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.
Intervention Type
Device
Intervention Name(s)
Chronic Training in the blind field
Intervention Description
After the initial training period of one to six months, the same computer software will continue to be used for all subjects. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 6 months.
Primary Outcome Measure Information:
Title
Direction Discrimination Threshold
Description
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.
Time Frame
baseline, 6 months, 12 months
Secondary Outcome Measure Information:
Title
Direction Integration Threshold
Description
This will measure the ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated 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.
Time Frame
baseline, 6 months, 12 months
Title
Contrast Sensitivity for Direction
Description
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination. For each subject, we will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that 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.
Time Frame
baseline, 6 months, 12 months
Title
contrast sensitivity for static orientation
Description
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination. For each subject, we will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that 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.
Time Frame
baseline, 6 months, 12 months
Title
Ganglion cell complex thickness laterality
Description
Change in thickness of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.** We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated thickness of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index LI as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant. **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Time Frame
baseline, 6 months, 12 months
Title
Ganglion cell complex volume laterality
Description
Change in volume of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.** We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated volume of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant. **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Time Frame
baseline, 6 months, 12 months
Title
Optic Tract (OT) laterality
Description
OT volume analysis will be performed from high resolution structural T1 MRI images of the brain. Mirrored masks of equal size will be hand-drawn over the OTs in each brain slice of a given subject, starting three slices posterior to the optic chiasm and continuing posteriorly until the OTs are no longer distinct from surrounding structures. The volume of each optic tract will be calculated from these masks by first establishing the maximum voxel intensity (range from 0 to 255) across the two OTs, then counting the number of voxels in each OT mask with brightness values between 5 and 85% of this maximum. We will then compute an OT laterality Index (LI85) to represent the relative difference in estimated volume between the two OTs of each participant, where LI85=(OTc-OTi)/(OTc+OTi), where OTc=number of voxels with brightness 5-85% of maximum in the contralesional OT and OTi = number of voxels with brightness 5-85% of maximum in the ipsilesional OT.
Time Frame
baseline, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
MAIA Visual Field Perimetry
Description
We will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.** **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Time Frame
baseline, 6 months, 12 months
Title
Humphrey 10-2 and 24-2 perimetry
Description
We will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.** **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Time Frame
baseline, 6 months, 12 months
Title
Goldmann perimetry
Description
We will measure the change in area of vision (degrees squared) as encompassed by each isopter, measured by one of 3 different light stimuli. The 3 isopters we will compare are: I2e 1asb, 0.25 mm^2 I4e 10asb, 0.25 mm^2 V4e 1000asb, 64 mm^2 These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.** **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Time Frame
baseline, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Residents of US and Canada MRI and/or CT scans showing evidence of 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 Inability to perform the visual training exercises as directed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chrys Callan
Phone
585-276-3426
Email
Christine_Callan@URMC.Rochester.Edu
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Callan
Phone
585-276-3426
Email
christine_callan@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Krystel Huxlin, PhD

12. IPD Sharing Statement

Learn more about this trial

Visual Rehabilitation After Occipital Stroke

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