VR System for Cross-modal Rehabilitation of Hemianopia

NCT ID: NCT04230486

Last Updated: 2022-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2021-07-30

Brief Summary

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The purpose of this research study is to investigate the effectiveness of a new rehabilitation for visual hemianopia. The study team believes a cross-modal rehabilitation technique delivered by a virtual reality system can help restore the visual field for subjects with homonymous hemianopia.

Detailed Description

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The study tests a novel rehabilitation system, translated from promising cross-modal rehabilitation animal research, that is the first treatment capable of restoring the visual field for hemianopia patients. This noninvasive technique uses a virtual reality device to deliver visual and auditory stimulus. The goals of this study are to obtain proof of concept and procure rehabilitation data to support the development of this novel rehabilitation treatment.

Conditions

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Hemianopia, Homonymous Hemianopsia, Homonymous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All study participants will be given the same treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental Group Virtual Reality (VR) Treatment

Visual Auditory Virtual Reality rehabilitation for visual hemianopia

Group Type EXPERIMENTAL

Cross-model Visual Auditory Rehabilitation

Intervention Type DEVICE

Subjects will put on a virtual reality rehabilitation system which will present sights and sounds.

Interventions

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Cross-model Visual Auditory Rehabilitation

Subjects will put on a virtual reality rehabilitation system which will present sights and sounds.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult volunteers diagnosed with homonymous visual hemianopia / hemianopsia (ages 18-99)

Exclusion Criteria

* Volunteers who are unable to complete the study tasks or understand instructions
* Subjects that are not able to provide written consent or verbal assent
* Subjects who are not available to complete all rehabilitation sessions
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huai Jiang, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00061542

Identifier Type: -

Identifier Source: org_study_id

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