Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia

NCT ID: NCT06638619

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-06-30

Brief Summary

This pilot study aims to understand how eye movements change in people with vision loss from stroke after completing one of two types of training. The study will look at how eye movements and reading performance change after training. Researchers will compare the results of two groups: one group will complete five clinical training sessions using an eye-tracking machine for 30 minutes each, while the other group will do at-home reading exercises for 20 minutes a day, 5 days a week, for 6 weeks. The goal is to see if there is a difference in performance between the two types of training.

Conditions

Hemianopia, Homonymous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biofeedback Fixation Arm

Biofeedback training is a mind-body therapy that helps people learn to control their involuntary bodily functions, such as eye movements. The goal is to improve eye movement control to improve gaze stability.

Group Type: EXPERIMENTAL

Biofeedback Fixation Training

Intervention Type: BEHAVIORAL

This training type involves the use of microperimetry. Microperimetry is a visual field test that incorporates perimetry and retinal imaging and is a standard ophthalmic clinical technology. It allows for direct observation of the fundus, but uses an eye-tracking system to compensate for involuntary eye movements. A program designed to train patients to direct and hold their gaze at an eccentric location programmed by the controller will be used. When the participant directs their gaze towards the pre-programmed location, a sound of increasing frequency is emitted to let them know they are approaching the correct location. The sound stabilizes into a solid tone when the patient is gazing directly at the trained location (biofeedback) and they are asked to attempt to hold their gaze at this location for as long as possible.

Saccadic Reading Arm

Saccadic reading training helps people to learn to control their involuntary eye movements. The goal is to improve eye movement control to improve saccadic and fixational behaviors during reading activities.

Group Type: ACTIVE_COMPARATOR

Saccadic Reading Training

Intervention Type: BEHAVIORAL

Participants will be assigned to participate in an at-home reading program. The reading exercises consist of worksheets with letter and number combinations of increasing complexity and font sizes. They are intended to increase accuracy in identifying letters and numbers. Worksheets will initially be dispensed with larger font type and spacing and be graded at weekly intervals towards regular, newspaper-size print and spacing over the course of training.

Interventions

Biofeedback Fixation Training

This training type involves the use of microperimetry. Microperimetry is a visual field test that incorporates perimetry and retinal imaging and is a standard ophthalmic clinical technology. It allows for direct observation of the fundus, but uses an eye-tracking system to compensate for involuntary eye movements. A program designed to train patients to direct and hold their gaze at an eccentric location programmed by the controller will be used. When the participant directs their gaze towards the pre-programmed location, a sound of increasing frequency is emitted to let them know they are approaching the correct location. The sound stabilizes into a solid tone when the patient is gazing directly at the trained location (biofeedback) and they are asked to attempt to hold their gaze at this location for as long as possible.

Intervention Type: BEHAVIORAL

Saccadic Reading Training

Participants will be assigned to participate in an at-home reading program. The reading exercises consist of worksheets with letter and number combinations of increasing complexity and font sizes. They are intended to increase accuracy in identifying letters and numbers. Worksheets will initially be dispensed with larger font type and spacing and be graded at weekly intervals towards regular, newspaper-size print and spacing over the course of training.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of stroke
• Presence of hemianopia with central vision involvement
• Stroke occurred at least 6-months before enrollment

Exclusion Criteria

• Presence of hemianopia with macular sparing
• Diagnosis of hemispatial neglect

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jason Eugene Vice

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Vice, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Central Contacts

Jason Vice, Ph.D.

Role: CONTACT

jasonvice@uabmc.edu

205-996-1374

Other Identifiers

000

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-300013228

Identifier Type: -

Identifier Source: org_study_id