Stroke, IschemicNCT04798924
Visual Rehabilitation After Occipital Stroke
A study testing Subacute Training in the intact field, Subacute Training in the blind field and Chronic Training in the blind field in people with Stroke, Ischemic and Quadrantanopia, run by University of Rochester at 1 site in United States.
Trial summary
This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Quadrantanopia, Vision Loss Partial
- What is being tested?
- Subacute Training in the intact field, Subacute Training in the blind field and Chronic Training in the blind field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2021to Jan 2028
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Residents of US and Canada
- MRI and/or CT scans showing evidence of one-sided / unilateral stroke or stroke-like damage to the primary visual cortex or its immediate afferent white matter sustained less than 6-months prior to enrollment
- Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
- Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
- Willing and safely able to undergo magnetic resonance imaging (MRI) scanning
- Willing, able, and competent to provide informed consent
- Fluent in written and spoken English
- Cognitively able, responsible, and willing to complete daily visual training independently at home for several months.
Who cannot join
- Past or present ocular disease interfering with vision
- Best corrected visual acuity worse than 20/40 in either eye
- Presence of damage to the dorsal Lateral Geniculate Nucleus, as shown on MRI/CT scans
- Diffuse, whole brain degenerative processes
- Brain damage deemed by study staff to potentially interfere with training ability or outcome measures
- History of traumatic brain injury
Show all 11Show fewer
- Documented history of drug/alcohol abuse
- Currently use of neuroactive medications which would impact training, as determined by PI
- Cognitive or seizure disorders
- One-sided attentional neglect
- Inability to perform the visual training exercises as directed
Trial locations and contacts
1 site in 1 country.
About this study
This research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.
- Conditions
- Stroke, Ischemic, Quadrantanopia, Vision Loss Partial, Visual Field Defect, Peripheral, Peripheral Visual Field Defect of Both Eyes, Peripheral Visual Field Defect
- Being tested
- Subacute Training in the intact field, Subacute Training in the blind field, Chronic Training in the blind field
- Keywords
- Occipital stroke, vision loss, Homonymous quadrantanopia, Homonymous quadrantanopsia, stroke, Vision loss after stroke, Vision recovery, Vision restoration, Partial vision loss
- Medical subject headings
- Ischemic Stroke, Hemianopsia, Hemorrhagic Stroke, Vision Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacute Training in the intact fieldDevice
A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the intact field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.
Subacute Training in the blind fieldDevice
A computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months.
Chronic Training in the blind fieldDevice
After the initial training period of one to six months, the same computer software will continue to be used for all subjects. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Training in the blind field | Experimental | Training in the blind field using specialized software Receives: Device: Subacute Training in the blind field; Device: Chronic Training in the blind field |
| Training in the intact field | Experimental | Training in the intact field using specialized software Receives: Device: Subacute Training in the intact field; Device: Chronic Training in the blind field |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direction Discrimination Threshold
For each subject, we will measure the ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance.
These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.**
**NOTE: Our protocol allows for a +1 month variance for all timepoints.
Measured: baseline, 6 months, 12 months
Secondary outcomes (6)
Direction Integration Threshold
This will measure the ability of subjects to integrate across a range of motion directions measured in degrees of visual angle. These assessments will be based on what range of motion directions can be reliably integrated at a 72-75% correct level of performance.
These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.
**NOTE: Our protocol allows for a +1 month variance for all timepoints.
Measured: baseline, 6 months, 12 months
Contrast Sensitivity for Direction
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for direction discrimination.
For each subject, we will measure the ability to correctly detect the motion direction of visual stimuli that are also varying in contrast against a grey background. We will measure the luminance contrast that can be reliably detected at a 72-75% correct level of performance.
These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.
**NOTE: Our protocol allows for a +1 month variance for all timepoints.
Measured: baseline, 6 months, 12 months
contrast sensitivity for static orientation
Assessment of visual perception transfer to untrained psychophysical tasks of contrast sensitivity for static orientation discrimination.
For each subject, we will measure the ability to correctly detect the orientation of non-moving visual stimuli that vary in contrast against a grey background. We will measure the luminance that can be reliably detected at a 72-75% correct level of performance.
These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.
**NOTE: Our protocol allows for a +1 month variance for all timepoints.
Measured: baseline, 6 months, 12 months
Ganglion cell complex thickness laterality
Change in thickness of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.**
We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated thickness of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index LI as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant.
**NOTE: Our protocol allows for a +1 month variance for all timepoints.
Measured: baseline, 6 months, 12 months
Ganglion cell complex volume laterality
Change in volume of the ganglion cell complex will be measured by retinal optical coherence tomography (OCT) scans from baseline to 6- and 12- months post stroke.**
We will perform OCT imaging of the foveal region of the retina (6mm ETDRS) in both eyes of each patient. Images will be automatically segmented. Estimated volume of the ganglion cell complex will be extracted and aligned with estimates of the blind field's visual sensitivity obtained from fundus-controlled MAIA perimetry. We will then compute a laterality index as follows: LIGCCT=(Tc-Ti)/(Tc+Ti) where Tc=thickness in the control lateral OCT quadrant, Ti=thickness in the impaired lateral OCT quadrant.
**NOTE: Our protocol allows for a +1 month variance for all timepoints.
Measured: baseline, 6 months, 12 months
Optic Tract (OT) laterality
OT volume analysis will be performed from high resolution structural T1 MRI images of the brain. Mirrored masks of equal size will be hand-drawn over the OTs in each brain slice of a given subject, starting three slices posterior to the optic chiasm and continuing posteriorly until the OTs are no longer distinct from surrounding structures. The volume of each optic tract will be calculated from these masks by first establishing the maximum voxel intensity (range from 0 to 255) across the two OTs, then counting the number of voxels in each OT mask with brightness values between 5 and 85% of this maximum. We will then compute an OT laterality Index (LI85) to represent the relative difference in estimated volume between the two OTs of each participant, where LI85=(OTc-OTi)/(OTc+OTi), where OTc=number of voxels with brightness 5-85% of maximum in the contralesional OT and OTi = number of voxels with brightness 5-85% of maximum in the ipsilesional OT.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start19 Jul 2021
- Primary completion26 Sep 2025
- Study completionJan 2028 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Krystel Huxlin, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798924
- Sponsor's protocol ID
- 00005966
- Other IDs
- R01EY027314
- Status last verified
- Nov 2025
- First submitted
- 25 Feb 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Rehabilitation After Occipital Stroke
- ClinicalTrials.gov ID
- NCT04798924
- Acronym / sponsor ID
- 00005966
- Conditions
- Stroke, Ischemic, Quadrantanopia, Vision Loss Partial, Visual Field Defect, Peripheral, Peripheral Visual Field Defect of Both Eyes, Peripheral Visual Field Defect
- Keywords
- Occipital stroke, vision loss, Homonymous quadrantanopia, Homonymous quadrantanopsia, stroke, Vision loss after stroke, Vision recovery, Vision restoration
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 26 Sep 2025 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Mar 2021 (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 research aims to examine changes in plastic potential of the visual system with time from stroke affecting primary visual cortex. We will measure structural and mechanistic aspects of progressive degeneration along the early visual pathways, correlating them with changes in visual performance, and in responsiveness to visual restoration training. This project will advance both scientific knowledge, as well as technical capability and clinical practices for restoring vision and quality of life for people suffering from cortical blindness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training in the blind field | Experimental | Device: Subacute Training in the blind field, Device: Chronic Training in the blind fieldTraining in the blind field using specialized software |
| Training in the intact field | Experimental | Device: Subacute Training in the intact field, Device: Chronic Training in the blind fieldTraining in the intact field using specialized software |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Residents of US and Canada
- MRI and/or CT scans showing evidence of one-sided / unilateral stroke or stroke-like damage to the primary visual cortex or its immediate afferent white matter sustained less than 6-months prior to enrollment
- Reliable visual field defects in both eyes as measured by Humphrey, Macular Integrity Assessment (MAIA), Goldmann, and/or equivalent perimetry. This deficit must be large enough to enclose a 5-deg diameter visual stimulus.
- Ability to fixate on visual targets reliably for 1000ms (as demonstrated by visual fields, and verified in study participation)
- Willing and safely able to undergo magnetic resonance imaging (MRI) scanning
Key exclusion criteria (11 listed)
- Past or present ocular disease interfering with vision
- Best corrected visual acuity worse than 20/40 in either eye
- Presence of damage to the dorsal Lateral Geniculate Nucleus, as shown on MRI/CT scans
- Diffuse, whole brain degenerative processes
- Brain damage deemed by study staff to potentially interfere with training ability or outcome measures
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 |
|---|---|---|
| Subacute Training in the intact fieldA computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the intact field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months. | Device | Training in the intact field |
| Subacute Training in the blind fieldA computer software and chin-rest necessary to perform visual training will be loaned to each subject to be used at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least one and up to 6 months. | Device | Training in the blind field |
| Chronic Training in the blind fieldAfter the initial training period of one to six months, the same computer software will continue to be used for all subjects. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a predetermined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. Subjects will train daily (about 40-60 minutes total), 5 to 7 days per week for at least 6 months. | Device | Training in the blind field, Training in the intact field |
Primary outcome
Direction Discrimination Threshold
Time frame: baseline, 6 months, 12 months
For each subject, we will measure the ability to detect differences in the motion direction of visual stimuli relative to horizontal, measured in degrees of visual angle. These assessments will be based on what can be reliably detected at a 72-75% correct level of performance. These measures of change will be evaluated baseline to 6-months post-stroke, then 6- to 12-months post stroke, and baseline to 12-months.** **NOTE: Our protocol allows for a +1 month variance for all timepoints.
6 secondary outcomes
Direction Integration Threshold
Time frame: baseline, 6 months, 12 months
Contrast Sensitivity for Direction
Time frame: baseline, 6 months, 12 months
contrast sensitivity for static orientation
Time frame: baseline, 6 months, 12 months
Ganglion cell complex thickness laterality
Time frame: baseline, 6 months, 12 months
Ganglion cell complex volume laterality
Time frame: baseline, 6 months, 12 months
Optic Tract (OT) laterality
Time frame: baseline, 6 months, 12 months
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 3 Dec 2025.
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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 Subacute Training in the intact field, Subacute Training in the blind field and Chronic Training in the blind field in people with Stroke, Ischemic and Quadrantanopia, 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 8 inclusion and 11 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 3 Dec 2025. 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?
Direction Discrimination Threshold (time frame: baseline, 6 months, 12 months). 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 3 Dec 2025.