Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies

Last updated: September 10, 2024
Sponsor: Kevin Houston
Overall Status: Active - Recruiting

Phase

N/A

Condition

Eye Disorders/infections

Neurologic Disorders

Treatment

Head-cancelled virtual reality

Clinical Study ID

NCT06417216
00001090
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 understandspoken English

Exclusion

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) thatwould 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 understandspoken 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) thatwould prevent them from wearing or tolerating a VR headset

  • Known inability to tolerate visual testing of at least 20 minutes continuously.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Head-cancelled virtual reality
Phase:
Study Start date:
September 10, 2024
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01605
    United States

    Active - Recruiting

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