CLINICAL TRIAL

Chronic Training in the blind field for Stroke

Recruiting · 18+ · All Sexes · Rochester, NY

This study is evaluating whether there are changes in plastic potential of the visual system with time from stroke affecting primary visual cortex.

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About the trial for Stroke

Eligible Conditions
Peripheral Visual Field Defect of Both Eyes · Visual Fields Hemianopsia · Homonymous Hemianopsia · Occipital Lobe Infarct · Visual Field Defect, Peripheral · Hemorrhagic Stroke · Quadrantanopsia · Ischemic Stroke · Vision Loss Partial · Homonymous Hemianopia · Hemianopsia · Stroke, Ischemic · Stroke · Quadrantanopia

Treatment Groups

This trial involves 2 different treatments. Chronic Training In The Blind Field is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
Subacute Training in the blind field
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Chronic Training in the blind field
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Experimental Group 2
Subacute Training in the intact field
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Chronic Training in the blind field
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Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person is able to think and is responsible show original
A person has a reliable visual field defect in both eyes if they have a measurement of the defect by Humphrey, MAIA, Goldmann, or equivalent perimetry that is large enough to enclose a 5-deg diameter visual stimulus. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: baseline, 6 months, 12 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: baseline, 6 months, 12 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Chronic Training in the blind field will improve 1 primary outcome, 6 secondary outcomes, and 3 other outcomes in patients with Stroke. Measurement will happen over the course of baseline, 6 months, 12 months.

Goldmann perimetry
BASELINE, 6 MONTHS, 12 MONTHS
We will measure the change in area of vision (degrees squared) as encompassed by each isopter, measured by one of 3 different light stimuli. The 3 isopters we will compare are: I2e 1asb, 0.25 mm^2 I4e 10asb, 0.25 mm^2 V4e 1000asb, 64 mm^2 These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.** **NOTE: Our protocol allows for a +1 month variance for all timepoints.
MAIA Visual Field Perimetry
BASELINE, 6 MONTHS, 12 MONTHS
We will measure the change in visual sensitivity (measured in decibels) at all locations tested by the system. These changes will be measured and compared between baseline, 6-months post stroke, and 12 months post stroke.** **NOTE: Our protocol allows for a +1 month variance for all timepoints.
Ganglion cell complex thickness laterality
BASELINE, 6 MONTHS, 12 MONTHS
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.
Direction Discrimination Threshold
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.
Optic Tract (OT) laterality
BASELINE, 6 MONTHS, 12 MONTHS
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.
Contrast Sensitivity for Direction
BASELINE, 6 MONTHS, 12 MONTHS
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.
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Who is running the study

Principal Investigator
K. H.
Prof. Krystel Huxlin, James V. Aquavella Professor of Ophthalmology, Associate Chair for Research, Dept. Ophthalmology
University of Rochester

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get stroke a year in the United States?

Approximately 534,000 Americans die from stroke a year. This is comparable to the number of [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) deaths, but almost twice as large as those from all other cancers combined.

Anonymous Patient Answer

What are common treatments for stroke?

Of all stroke patients in a community, 8% were being treated with aspirin, 33% with statins, and 15% with drugs to prevent VTE. Antihypertensive agents were administered to less than 20% of the population. Thrombolytic therapy is widely used in the early treatment of stroke.

Anonymous Patient Answer

Can stroke be cured?

The question of whether one can cure oneself of an ipsilateral ischemic stroke remains unresolved. Future studies should focus on whether it is possible to prevent other strokes.

Anonymous Patient Answer

What are the signs of stroke?

The signs of the stroke may be similar to those of a heart attack, although a heart attack can occur without the signs appearing in most cases.\n

Anonymous Patient Answer

What causes stroke?

The cause of stroke is not completely understood, but there are identifiable risk factors for stroke to be a woman, age 60 and older, diabetes, heart disease, and atherosclerosis.

Anonymous Patient Answer

What is stroke?

Stroke is a condition in which the brain acquires a shortage of blood supply (ischemia) which can lead to a temporary or permanent loss of function. Most common in people over 65 years of age, strokes occur when an artery supplying blood (typically, the blood vessels that emerge from the brain's brain) becomes blocked, and there is an insufficient amount of blood flowing through this artery, leading to a lack of oxygenated blood in the brain tissue. The loss of oxygen can damage the cells that make up the nerve membrane in the brain, leading to a neurological condition called a stroke.

Anonymous Patient Answer

Who should consider clinical trials for stroke?

Although there seems to be a consensus that a majority of patients with a first clinical episode of stroke should undergo a trial of medication, a discrepancy exists in patient selection between trial providers and providers of stroke care. Inclusion and exclusion criteria are used inconsistently, resulting in suboptimal patient-provider communication and communication between the healthcare system and trial providers. There remains a lack of evidence-based guidelines and an undefined gap between guideline recommendations and current practice. Further education and clinical trials focused on addressing selection criteria for clinical trials of stroke treatment could improve patient outcomes during time of the acute stroke.

Anonymous Patient Answer

What is the average age someone gets stroke?

When a stroke happens, there is a peak in number of strokes during the third and fourth decades. Therefore, education about stroke in the population should be initiated at least during the early thirties, in order to protect the population against stroke when they grow up.

Anonymous Patient Answer

Have there been other clinical trials involving chronic training in the blind field?

Findings from a recent study of our study showed that training in the blind field with a specialised visuomotor rehabilitation system has the potential to produce gains in performance. Findings from a recent study of this study have relevance for a range of neurodegenerative disorders and underscore previous findings that cognitive training in the brain-lesioned hemisphere is beneficial.

Anonymous Patient Answer

What does chronic training in the blind field usually treat?

It was determined that the specific training for the blind that is used in the study is effective in the treatment of this unilateral chronic visual loss.

Anonymous Patient Answer

What is chronic training in the blind field?

In a recent study, findings indicate that there is no significant change in the sensory function or visual field in the blind field after intensive training. The improvement found in the amplitude of P100 and N170 in the test subjects suggests that this training has had an improvement in temporal resolution. The significant decrease in P100 amplitude in the second session compared to baseline implies that this is possibly related to the learning of the visual stimulus. The significant improvement observed in the N170 amplitude at baseline and during the second session indicates the development of a visual perception before the training. In a recent study, findings emphasize the role of training in the blind field in which visual development and training in the blindness are important in the rehabilitation.

Anonymous Patient Answer

What is the primary cause of stroke?

Two strokes have relatively benign ischemic presentations with a low stroke burden compared with four strokes. The relative benignity of strokes occurring in 4 strokes may be explained by the frequent occurrence of small vessel disease in 4 strokes.

Anonymous Patient Answer
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