Clinical trial NCT06578117: Statistical Learning As a Novel Intervention for Cortical Blindness
Official title: Statistical Learning As a Novel Intervention for Cortical Blindness
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke, Ischemic
Hemianopia, Homonymous
Hemianopsia
Occipital Lobe Infarct
Visual Field Defect, Peripheral
Vision Loss Partial
Quadrantanopia
Stroke Hemorrhagic
Keywords: occipital stroke
vision loss after stroke
vision recovery
vision restoration
partial vision loss
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to develop a novel visual training paradigm for use in visually-intact participants and those sufferings from stroke-induced visual impairments. Our task design is built upon theories of statistical learning to reduce the overall training burden while still producing profound improvements to visual abilities. Efficacy will be first established in visually-intact controls before testing in stroke survivors to assess the feasibility of this form of learning in the damaged visual system.


Eligibility criteria: Cortically Blind participants

Inclusion criteria:

* Between 21 and 75 years of age
* Residents of the United States or Canada
* Have successfully completed previous enrollment in Dr. Huxlin study (IRB #5966 or #75)
* Exhibit unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained within the specified age range of 21 - 75 years (verified by MRI and/or CT scans)
* Reliable visual field defects in both eyes (homonymous defects) as measured by Humphrey visual fields. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
* Able to fixate on visual targets reliably for 1000ms within 1-deg of visual angle.
* Willing, able, and competent to provide their own informed consent
* Normal cognitive abilities and be able to understand written and oral instructions in English

Exclusion criteria:

* Past or present ocular disease interfering with visual acuity
* Best corrected visual acuity (BCVA) worse than 20/40 in either eye
* Sustained documented or suspected damage to the dorsal Lateral Geniculate Nucleus
* Presence of diffuse whole brain degenerative processes
* History of traumatic brain injury
* Any other brain damage deemed by study staff to potentially interfere with training ability or outcome measures
* Documented history of drug/alcohol abuse
* Currently taking neuroactive medications which would impact training, as determined by PI
* Cognitive or seizure disorders
* One-sided attentional neglect
* Those who lack the competence or are otherwise unable to perform the visual training exercises as directed.

Control participants

Inclusion criteria:

* Between 21 and 75 years of age
* No history of neurological disorder.
* Competent and responsible, as determined by the screening interview

Exclusion criteria:

* Any damage to the visual system
* Those who are suffering from an active disease process involving their nervous system.
* Presence of cognitive or seizure disorders
* Best corrected visual acuity worse than 20/40 in either eye
* Presence of visual field loss from ocular disease or disorder

Primary outcomes:
measure: Explicit Learning - Response Time
timeFrame: Baseline
measure: Implicit Learning - Triplet Familiarity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References: