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Statistical Learning As a Novel Intervention for Cortical Blindness

NCT ID: NCT06578117

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-06

Study Completion Date

2027-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Ischemic Hemianopia, Homonymous Hemianopsia Occipital Lobe Infarct Visual Field Defect, Peripheral Vision Loss Partial Quadrantanopia Stroke Hemorrhagic

Keywords

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occipital stroke vision loss after stroke vision recovery vision restoration partial vision loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Visual Training in Cortically Blind cohort

Group Type EXPERIMENTAL

Vision Training and Learning Task

Intervention Type DEVICE

Participants will be seated at a computer, and will be shown a random-noise visual stimulus drifting in one of eight directions. Participants will be instructed to indicate the direction of motion they perceive using a Sony Access Controller or a computer keyboard. Sound cues during stimulus presentation will also be used to ensure participants are aware of stimulus onset during the training task.

After several repetitions of this visual training, a second set of visual cues will be presented to evaluate participant's learning of the program. Responses will be provided in the same manner by input from the controller or the keyboard.

Visual Training in Control cohort

Group Type EXPERIMENTAL

Vision Training and Learning Task

Intervention Type DEVICE

Participants will be seated at a computer, and will be shown a random-noise visual stimulus drifting in one of eight directions. Participants will be instructed to indicate the direction of motion they perceive using a Sony Access Controller or a computer keyboard. Sound cues during stimulus presentation will also be used to ensure participants are aware of stimulus onset during the training task.

After several repetitions of this visual training, a second set of visual cues will be presented to evaluate participant's learning of the program. Responses will be provided in the same manner by input from the controller or the keyboard.

Interventions

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Vision Training and Learning Task

Participants will be seated at a computer, and will be shown a random-noise visual stimulus drifting in one of eight directions. Participants will be instructed to indicate the direction of motion they perceive using a Sony Access Controller or a computer keyboard. Sound cues during stimulus presentation will also be used to ensure participants are aware of stimulus onset during the training task.

After several repetitions of this visual training, a second set of visual cues will be presented to evaluate participant's learning of the program. Responses will be provided in the same manner by input from the controller or the keyboard.

Intervention Type DEVICE

Eligibility Criteria

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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


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

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


* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Matthew Cavanaugh

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00009495

Identifier Type: -

Identifier Source: org_study_id