Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06417216

Head-Cancelled Virtual Reality for 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brooks Rehabilitation Hospital, Jacksonville, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Head-cancelled virtual reality

Behavioral

Scene in virtual reality moves with the head while performing visual tasks.

Primary outcomes

  1. Peak saccade amplitude

    Time frame: 5 minutes

    Maximum amplitude of eye movement

Secondary outcomes

  1. Mean head position

    Time frame: 5 minutes

    Mean deviation of the head from the neutral position during each task

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Houston, OD

CONTACT

[email protected]

508-753-5103

Shelli Levasseur, BS

CONTACT

[email protected]

5087535103

Sponsors and collaborators

Lead sponsor

Kevin Houston

Other

Collaborators

  • American Academy of Optometry

Registry information

Official study title

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

Acronym: OCNP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 16, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.