Stroke, IschemicNCT06578117
Statistical Learning as a Novel Intervention for Cortical Blindness
A study testing Vision Training and Learning Task in people with Stroke, Ischemic and Hemianopia, Homonymous, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Hemianopia, Homonymous, Hemianopsia
- What is being tested?
- Vision Training and Learning Task
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
- Conditions
- Stroke, Ischemic, Hemianopia, Homonymous, Hemianopsia, Occipital Lobe Infarct, Visual Field Defect, Peripheral, Vision Loss Partial
- Being tested
- Vision Training and Learning Task
- Keywords
- occipital stroke, vision loss after stroke, vision recovery, vision restoration, partial vision loss
- Medical subject headings
- Ischemic Stroke, Hemianopsia, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision Training and Learning TaskDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Visual Training in Cortically Blind cohort | Experimental | Not described Receives: Device: Vision Training and Learning Task |
| Visual Training in Control cohort | Experimental | Not described Receives: Device: Vision Training and Learning Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start6 Nov 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystel Huxlin, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578117
- Sponsor's protocol ID
- STUDY00009495
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statistical Learning as a Novel Intervention for Cortical Blindness
- ClinicalTrials.gov ID
- NCT06578117
- Acronym / sponsor ID
- STUDY00009495
- Conditions
- Stroke, Ischemic, Hemianopia, Homonymous, Hemianopsia, Occipital Lobe Infarct, Visual Field Defect, Peripheral, Vision Loss Partial
- Keywords
- occipital stroke, vision loss after stroke, vision recovery, vision restoration, partial vision loss
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vision Training and Learning TaskParticipants 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. | Device | Visual Training in Control cohort, Visual Training in Cortically Blind cohort |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision Training and Learning Task in people with Stroke, Ischemic and Hemianopia, Homonymous, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Explicit Learning - Response Time (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.