Comparative Efficacy of Saccadic and Biofeedback Training in Homonymous Hemianopia

NCT06638619 | Not Yet Recruiting

• 2 other identifiers: IRB-300013228000
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

stroke; vision; hemianopia

Outcome Measures

Primary Outcomes (1)

• Oculomotor Metrics

  Participants will be asked to read aloud a series of sentences presented on a display. Eye movements will be recorded in real-time using an Eye-Link 1000 infrared eye-tracking camera, as the patient is reading what is on the display. The primary outcome measure will be the first saccade landing location.

  Pre-training and at 6-weeks.

Secondary Outcomes (1)

• Pepper Visual Skills Reading Test (VSRST)

  Pre-training and at 6-weeks.

Study Arms (2)

Biofeedback Fixation Arm

EXPERIMENTAL

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.

Behavioral: Biofeedback Fixation Training

Saccadic Reading Arm

ACTIVE COMPARATOR

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.

Behavioral: Saccadic Reading Training

Interventions

Saccadic Reading Training 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.

Saccadic Reading Arm

Biofeedback Fixation Training 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.

Biofeedback Fixation Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Hemianopsia; Stroke

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jason Vice, Ph.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Vice, Ph.D.

CONTACT

205-996-1374; jasonvice@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 15, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01