- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06352086
Understanding Visual Processing After Occipital Stroke
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chrys Callan
- Phone Number: 585-276-3426
- Email: Christine_Callan@URMC.Rochester.Edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Residents of the United States or Canada
- MRI and/or CT scans showing unilateral stroke or stroke-like damage to primary visual cortex or its immediate afferent white matter sustained 1-year or more 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, able, and competent to provide informed consent
- Cognitively able to understand and respond to written and oral instructions in English
Exclusion Criteria:
- Past or present ocular disease interfering with visual acuity
- Corrected vision worse than 20/40 in either eye
- Presence of damage to the dorsal Lateral Geniculate Nucleus
- Diffuse, whole brain degenerative processes
- Brain damage deemed by study staff to potentially interfere with testing ability or outcome measures
- Documented history of traumatic brain injury
- Documented history of drug/alcohol abuse
- Current use neuroactive
- Cognitive or seizure disorders
- Subjects with one-sided attentional neglect
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Orientation discrimination threshold
Time Frame: Baseline
|
Assessment of Static Orientation Discrimination. For each subject, the investigators will measure the ability to correctly identify the orientation of non-moving visual stimuli that vary in degree of angle tilt to the right or left of vertical. The investigators will measure the degree of angle tilt that can be reliably detected at a 72-75% correct level of performance. Tilt difference from vertical will vary between 80° (maximum) and 0.1° (minimum) based on subject performance and an adaptive staircase that will change tilt magnitude depending on subject performance, increasing the tilt (making the task easier) for each incorrect answers and decreasing tilt (making the task harder) after a number of correct answers in a row. |
Baseline
|
Perceptual Confidence in Orientation Discrimination
Time Frame: Baseline
|
Assessment of Metacognition (i.e., perceptual confidence) in Orientation Discrimination. For each subject, the investigators will measure their confidence in identifying an object's tilt to the right or left of vertical. A running tally of 'response points' will be collected during the orientation testing. Points will be awarded for each response on a scale, with the highest points awarded for "correct discrimination & high confidence", intermediate points awarded for "correct discrimination & low confidence", followed by "incorrect discrimination & low confidence" and with points subtracted for "incorrect discrimination & high confidence". Total points will be recorded for each test, with the patient asked to accumulate the highest number of points they can during the task. |
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Sensation Disorders
- Vision Disorders
- Infarction
- Stroke
- Ischemic Stroke
- Blindness
- Hemianopsia
- Blindness, Cortical
Other Study ID Numbers
- STUDY00009227
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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