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Not Yet RecruitingNCT05894434

Ameliorating Stroke-induced Hemianopia Via Multisensory Training

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
72 (estimated)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMultisensory TrainingThe procedure involves repeatedly presenting identical visual-auditory stimuli at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°). The visual (a 500 ms flash) and auditory (500 ms broadband noise burst) stimuli are in spatial and temporal congruence.
BEHAVIORALUnisensory TrainingThe procedure involves repeatedly presenting identical auditory stimuli (500 ms broadband noise burst) at a single location in the hemianopic field (initially at 45° of eccentricity along the azimuth) while the patient maintains central fixation (0°, 0°).

Timeline

Start date
2026-04-01
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2023-06-08
Last updated
2026-02-27

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05894434. Inclusion in this directory is not an endorsement.