NCT06578117

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
17mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Nov 2024Oct 2027

First Submitted

Initial submission to the registry

August 27, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

August 27, 2024

Last Update Submit

January 28, 2026

Conditions

Keywords

occipital strokevision loss after strokevision recoveryvision restorationpartial vision loss

Outcome Measures

Primary Outcomes (2)

  • Explicit Learning - Response Time

    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

    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

Study Arms (2)

Visual Training in Cortically Blind cohort

EXPERIMENTAL
Device: Vision Training and Learning Task

Visual Training in Control cohort

EXPERIMENTAL
Device: Vision Training and Learning Task

Interventions

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 cohortVisual Training in Cortically Blind cohort

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Between 21 and 75 years of age
  • No history of neurological disorder.
  • Competent and responsible, as determined by the screening interview
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Ischemic StrokeHemianopsiaHemorrhagic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesVision DisordersSensation DisordersNeurologic ManifestationsBlindnessEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

August 27, 2024

First Posted

August 29, 2024

Study Start

November 6, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations