Clinical trial NCT04798924: Visual Rehabilitation After Occipital Stroke
Official title: Visual Rehabilitation After Occipital Stroke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2021-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* Inability to perform the visual training exercises as directed

Primary outcomes:
measure: Direction Discrimination Threshold
timeFrame: baseline, 6 months, 12 months
Secondary outcomes:
measure: Direction Integration Threshold
timeFrame: baseline, 6 months, 12 months
measure: Contrast Sensitivity for Direction
timeFrame: baseline, 6 months, 12 months
measure: contrast sensitivity for static orientation
timeFrame: baseline, 6 months, 12 months
measure: Ganglion cell complex thickness laterality
timeFrame: baseline, 6 months, 12 months
measure: Ganglion cell complex volume laterality
timeFrame: baseline, 6 months, 12 months
measure: Optic Tract (OT) laterality
timeFrame: baseline, 6 months, 12 months
Other outcomes:
measure: MAIA Visual Field Perimetry
timeFrame: baseline, 6 months, 12 months
measure: Humphrey 10-2 and 24-2 perimetry
timeFrame: baseline, 6 months, 12 months
measure: Goldmann perimetry
timeFrame: baseline, 6 months, 12 months
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
References: