Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT05894434
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
Ameliorating Stroke-induced Hemianopia Via Multisensory Training
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study seeks to determine the extent of the visual capabilities that can be restored in hemianopic stroke patients by a multisensory training technique and evaluate changes in the brain that the training induces. The effectiveness of the technique will be evaluated in two interventional contexts: patients whose blindness is long-standing and stable, and another in which intervention is as soon as possible after the stroke.
Detailed Description:
The aims of the study are to:
1\. To identify the visual capabilities and neural circuits in stroke patients with stable hemianopia (\>6 months) that recover after regular multisensory (vs. unisensory) training sessions. This involves:
1A. Using clinical ophthalmological tests and visual perceptual tests to evaluate the visual capabilities that are recovered.
1B. Determining whether the size or extent of cortical lesions are predictive of changes induced by the training technique, and tracking changes in the residual visual circuits using functional magnetic resonance imaging (fMRI).
1C. Determining if the training-induced changes improve, persist, or degrade over time by re-assessment at a 12-month followup.
2\. Evaluate the effectiveness of an earlier (\<1 month post-stroke) and more intense training intervention strategy using the above approach and comparing the outcomes in these two approaches.
1\. To identify the visual capabilities and neural circuits in stroke patients with stable hemianopia (\>6 months) that recover after regular multisensory (vs. unisensory) training sessions. This involves:
1A. Using clinical ophthalmological tests and visual perceptual tests to evaluate the visual capabilities that are recovered.
1B. Determining whether the size or extent of cortical lesions are predictive of changes induced by the training technique, and tracking changes in the residual visual circuits using functional magnetic resonance imaging (fMRI).
1C. Determining if the training-induced changes improve, persist, or degrade over time by re-assessment at a 12-month followup.
2\. Evaluate the effectiveness of an earlier (\<1 month post-stroke) and more intense training intervention strategy using the above approach and comparing the outcomes in these two approaches.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: