Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies

NCT06417216 | Suspended

• 1 other identifier: Pro00084433
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Internuclear Ophthalmoplegia; Palsy, Abducens

Outcome Measures

Primary Outcomes (1)

• Peak saccade amplitude

  Maximum amplitude of eye movement

  5 minutes

Secondary Outcomes (1)

• Mean head position

  5 minutes

Study Arms (2)

Head Cancelled

EXPERIMENTAL

Study tasks performed in head-cancelled conditions

Behavioral: Head-cancelled virtual reality

Normal

NO INTERVENTION

Study tasks performed in normal conditions.

Interventions

Head-cancelled virtual reality BEHAVIORAL

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

Head Cancelled

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Kevin Houston: lead
• American Academy of Optometry: collaborator

Study Sites (1)

Brooks Rehabilitation Hospital

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Ocular Motility Disorders; Abducens Nerve Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Kevin E Houston, OD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: Subjects perform study tasks under head-active conditions, and then are crossed over to the head-cancelled condition.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)