Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies (OCNP)

April 1, 2026 updated by: Kevin Houston

Head-Cancelled Virtual Reality for Rehabilitation of Ocular Cranial Nerve Palsies

This study is investigating whether eye exercises for abducens palsy and internuclear ophthalmoplegia increase ocular range of motion in the paretic direction when performed in virtual reality under head-cancelled compared to head-active conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Participants with abducens palsy or internuclear ophthalmoplegia, two common types of ocular cranial nerve palsies, will perform 3 different tasks in virtual reality under head-cancelled and head-active conditions. Head active is the normal state, where gaze can be shifted by moving the head, the eyes, or a combination of the two. Head-cancelled refers to the condition where the scene moves with the head, rendering head movement ineffective to shift gaze. In this condition, the eyes must move in order to shift gaze. The hypothesis is that this requirement for eye movement will result in larger eye movements, which could be therapeutic. The tasks performed under the two conditions will include horizontal transposition of coins, repetitive horizontal saccades, and game play. The primary analysis will be a within subject's comparison of eye movement amplitude in head-cancelled (experimental) versus head-active (control) conditions. Additionally, as a control comparison for secondary analysis, a group with normal vision will also perform the tasks under both conditions.

Study Type

Interventional

Enrollment (Estimated)

40

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 Contact Backup

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
    • Massachusetts
      • Worcester, Massachusetts, United States, 01610

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

Yes

Description

OCNP Group Inclusion Criteria:

  • Presence of OCNP in one eye with 50% range-of-motion limitation or worse
  • Able to provide informed consent and will be able to fluently read and understand spoken English

OCNP Group Exclusion Criteria:

  • Presence of bilateral OCNP
  • Range of motion better than 50%
  • Visual acuity worse than 20/100 in either eye
  • Greater than 4-line difference in visual acuity between the eyes,
  • Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset

Participants will be excluded if they are unable to participate if inclusion criteria are not met.

Normal Group Inclusion Criteria:

  • Absence of OCNP or other neurological or neuro-ophthalmic diseases
  • No strabismus
  • Have normal or near-normal vision with glasses or contact lenses.
  • Be able to provide informed consent and will be able to fluently read and understand spoken English

Normal Group Exclusion Criteria:

  • Visual acuity worse than 20/100 in either eye
  • Greater than 4-line difference in visual acuity between the eyes
  • Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset
  • Known inability to tolerate visual testing of at least 20 minutes continuously.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Head Cancelled
Study tasks performed in head-cancelled conditions
Behavioral: Head-cancelled virtual reality
Scene in virtual reality moves with the head while performing visual tasks.
No Intervention: Normal
Study tasks performed in normal conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak saccade amplitude
Time Frame: 5 minutes
Maximum amplitude of eye movement
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean head position
Time Frame: 5 minutes
Mean deviation of the head from the neutral position during each task
5 minutes

Collaborators and Investigators

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

Sponsor

Kevin Houston

Collaborators

American Academy of Optometry

Investigators

  • Study Director: Kevin E Houston, OD

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 (Actual)

September 10, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00084433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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