Mixed-Reality Visual Attention Task for Neglect Diagnosis and Rehabilitation (Neglex01)

November 11, 2025 updated by: Markey Olson

Pilot Study of a Mixed-Reality Visual Attention Task for Neglect Diagnosis and Rehabilitation

Neglect, a common and disabling neurological deficit post-CNS injury, profoundly hinders recovery and escalates healthcare costs. Current diagnostic tools are often insensitive or impractical, and while therapies exist, a significant research gap remains. Traditional methods, including standardized scales and paper-pencil tests, lack precision; even advanced video oculography is limited by cost and accessibility. Rehabilitative approaches like visual scanning and prism adaptation offer some benefit, but more effective solutions are needed. This project utilizes a non-invasive neuromodulatory training approach via a mixed-reality visual attention task delivered through a virtual reality headset. This system aims to improve both neglect diagnosis and personalized therapeutic intervention. The study will assess the headset's safety and practicality, its capacity to detect and lateralize neglect, and its long-term effect on improving attention to the neglected field. By measuring reaction times to visual stimuli within the VR environment, the research seeks to develop a more accessible and impactful tool for both assessing and treating neglect, potentially enabling self-directed therapy and enhancing patient outcomes.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The study will involve patients over the age of 18 who have been diagnosed with a neurological injury that includes: ischemic stroke, hemorrhagic stroke, tumor, or trauma.
  • Neurological injury that localizes to only one side of the brain
  • At least one hand that retains dexterity enough to use a controller to extinguish the visual stimulus.
  • Cognitive ability to understand simple instructions on how to use the device
  • Visual fields intact

Exclusion Criteria:

  • Bilateral symptomatic injury
  • Inability to consent or to comply with study
  • Blindness or severe visual deficits other than neglect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
VR Neglect Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Neglect
Time Frame: 6 months
Measured as improvement in percentage of lines detected at each location in the VR app
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility/Usage, sessions
Time Frame: 6 months
Number of sessions completed by each participant
6 months
Feasibility/Usage, time
Time Frame: 6 months
Total time spent using the device
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 31, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 11, 2025

First Posted (Estimated)

November 13, 2025

Study Record Updates

Last Update Posted (Estimated)

November 13, 2025

Last Update Submitted That Met QC Criteria

November 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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