Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies

Internuclear Ophthalmoplegia Clinical Trial

— OCNP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417216
• Other study ID #: 00001090
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: University of Massachusetts, Worcester
• Contact: Kevin Houston, OD
• Phone: 7744418745
• Email: kevin.houston[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cranial Nerve Diseases
• Internuclear Ophthalmoplegia
• Ocular Motility Disorders
• Ophthalmoplegia

Intervention

Behavioral:
• Head-cancelled virtual reality
Scene in virtual reality moves with the head while performing visual tasks.

Locations

Country	Name	City	State
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Kevin Houston	American Academy of Optometry

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak saccade amplitude	Maximum amplitude of eye movement	5 minutes
Secondary	Mean head position	Mean deviation of the head from the neutral position during each task	5 minutes