Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies

NCT ID: NCT06417216

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-06-01

Brief 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.

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.

Conditions

Internuclear Ophthalmoplegia; Palsy, Abducens

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Head Cancelled

Study tasks performed in head-cancelled conditions

Group Type: EXPERIMENTAL

Head-cancelled virtual reality

Intervention Type: BEHAVIORAL

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

Normal

Study tasks performed in normal conditions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Head-cancelled virtual reality

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

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

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Academy of Optometry

OTHER

Sponsor Role: collaborator

Kevin Houston

OTHER

Sponsor Role: lead

Responsible Party

Kevin Houston

Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kevin E Houston, OD

Role: STUDY_DIRECTOR

Locations

Brooks Rehabilitation Hospital

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

Pro00084433

Identifier Type: -

Identifier Source: org_study_id