- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06578117
Statistical Learning as a Novel Intervention for Cortical Blindness
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visual Training in Cortically Blind cohort
|
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. |
|
Experimental: Visual Training in Control cohort
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Explicit Learning - Response Time
Time Frame: Baseline
|
Reaction time (ms) when performing motion discriminations for the final stimulus of a statistically-linked triplet will be compared against reaction times for stimuli with identical motion directions, presented with alternative placement within a triplet.
Comparisons will be made only for correct responses in the final 20% of overall testing session trials.
|
Baseline
|
|
Implicit Learning - Triplet Familiarity
Time Frame: Baseline
|
Participant familiarity with statistically-linked triplets of motion will be assessed via a two-interval, forced-choice task.
Familiarity will be measured as a percentage of comparisons in which the more prevalent triplet is selected as more familiar.
Familiarity of high-probability, low-probability, and null-probability triplets will be compared following training.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Eye Diseases
- Vision Disorders
- Sensation Disorders
- Blindness
- Stroke
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Ischemic Stroke
- Hemorrhagic Stroke
- Hemianopsia
Other Study ID Numbers
- STUDY00009495
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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