Multisensory Rehabilitation of Hemianopia

NCT04963075 | Completed Results FDA Device

• 1 other identifier: IRB00074687
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The current proposal is to generate "proof of concept" evidence that hemianopia can be successfully rehabilitated in humans when this multisensory rehabilitation paradigm is used.

Conditions

Hemianopia

Keywords

visual cortex injury; stroke; blindness; cortical damage

Outcome Measures

Primary Outcomes (1)

• Number of Points Detected at Multiple Locations

  To assess recovery of function - number of detected visual points in both hemifields (discrete count variable, higher values are "better") - Visual fields are divided into "affected" areas of the field (detection \< 50% on initial testing) and "intact" areas of the field (detection \> 50% on initial testing), aggregate data are reported for each at the start and end of study

  Month 3

Other Outcomes (6)

• Low-vision Visual Functioning Questionnaire (LV-VFQ-48)

  Baseline

• Low-vision Visual Functioning Questionnaire (LV-VFQ-48)

  Month 3

• Humphrey Visual Field Test

  Baseline

Study Arms (1)

Unilaterally blind Subjects will be exposed to visual-auditory stimulation

EXPERIMENTAL

The over-arching objective is to evaluate the functional recovery of vision in hemianopic patients engaged with a multisensory training paradigm. Unilaterally blind participants will participate in weekly training sessions in which they are exposed to high-density spatiotemporally congruent and consistent visual-auditory stimulation. The participants will be tested on a battery of visual tasks probing different levels of function in different environments in a longitudinal study to track recovery.

Device: multisensory rehabilitation paradigm

Interventions

multisensory rehabilitation paradigm DEVICE

In initial ("training") sessions, subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between "training/testing" and "testing only" sessions in which performance on the visual battery will be re-assessed.

Unilaterally blind Subjects will be exposed to visual-auditory stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults (\<85) of either sex
• diagnosis of a stable homonymous hemianopia (\>6 months) with absence of hemineglect
• lesion encompassing at least primary visual cortex but sparing parietal cortex
• normal auditory and cognitive function
• willingness to participate in the three month program
• ability to perform the visual discriminations in their intact field

You may not qualify if:

• adults (\>85)
• normal auditory and cognitive function
• unwilling to participate in the three month program
• inability to perform the visual discriminations in their intact field

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Neuroscience Clinical Trial and Innovation Center (NCTIC): collaborator

Study Sites (1)

Wake Forest Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Hemianopsia; Stroke; Blindness

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Benjamin Rowland, MD
• Organization: Wake Forest University Health Sciences

Benjamin.Rowland@wfusm.edu

704-355-2000

Study Officials

• Benjamin Rowland, PhD

  Wake Forest Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will participate in weekly sessions (1.5-2 hours) for three months which contain baseline testing, training, and repeated testing of visual recovery

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: September 22, 2021
• Primary Completion: March 18, 2025
• Study Completion: September 30, 2025
• Last Updated: April 30, 2026
• Results First Posted: April 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication
• Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months, the data will be available in our University's data warehouse but without investigator support other than deposited metadata.

Locations

US (1)