Internuclear OphthalmoplegiaOCNPNCT06417216
Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies
A study testing Head-cancelled virtual reality in people with Internuclear Ophthalmoplegia and Palsy, Abducens, run by Kevin Houston at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Internuclear Ophthalmoplegia, Palsy, Abducens
- What is being tested?
- Head-cancelled virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Sep 2024to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brooks Rehabilitation Hospital
Jacksonville, Florida, 32216
Hannah Grimes, 904-345-7373, Hannah.Grimes@Brooksrehab.org
Katelyn Jordan, OD, 904-345-7373, katelyn.jordan@brooksrehab.org
- Recruiting
Vision Source of Worcester
Worcester, Massachusetts, 01610
Kevin E Houston, OD, 508-753-5103, khouston@wsvisionsource.com
Shelli Levasseur, 508-753-5103, mlevasseur@wsvisionsource.com
About this study
Official title: Head-Cancelled Virtual Reality for Rehabilitation of 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.
Read the 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
- Being tested
- Head-cancelled virtual reality
- Medical subject headings
- Ocular Motility Disorders, Abducens Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-cancelled virtual realityBehavioural
Scene in virtual reality moves with the head while performing visual tasks.
| Study group | Role | What they receive |
|---|---|---|
| Head Cancelled | Experimental | Study tasks performed in head-cancelled conditions Receives: Behavioral: Head-cancelled virtual reality |
| Normal | No intervention | Study tasks performed in normal conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak saccade amplitude
Maximum amplitude of eye movement
Measured: 5 minutes
Secondary outcomes (1)
Mean head position
Mean deviation of the head from the neutral position during each task
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internuclear OphthalmoplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects perform study tasks under head-active conditions, and then are crossed over to the head-cancelled condition.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kevin Houston
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Optometry
- Responsible party
- Sponsor-investigator, Kevin Houston, Brooks Rehabilitation
- Investigators
- Kevin E Houston, OD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417216
- Sponsor's protocol ID
- Pro00084433
- Acronym
- OCNP
- Status last verified
- Apr 2026
- First submitted
- 13 May 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head-Cancelled Virtual Reality for Rehabilitation of Ocular Cranial Nerve Palsies
- ClinicalTrials.gov ID
- NCT06417216
- Acronym / sponsor ID
- OCNP / Pro00084433
- Conditions
- Internuclear Ophthalmoplegia, Palsy, Abducens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kevin HoustonUniversity, hospital or other
- Collaborators
- American Academy of Optometry
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects perform study tasks under head-active conditions, and then are crossed over to the head-cancelled condition.
| Arm | Type | Receives |
|---|---|---|
| Head Cancelled | Experimental | Behavioral: Head-cancelled virtual realityStudy tasks performed in head-cancelled conditions |
| Normal | No intervention | –Study tasks performed in normal conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head-cancelled virtual realityScene in virtual reality moves with the head while performing visual tasks. | Behavioural | Head Cancelled |
Primary outcome
Peak saccade amplitude
Time frame: 5 minutes
Maximum amplitude of eye movement
1 secondary outcome
Mean head position
Time frame: 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kevin E Houston, OD study director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head-cancelled virtual reality in people with Internuclear Ophthalmoplegia and Palsy, Abducens, run by Kevin Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Houston, OD (508-753-5103, khouston@wsvisionsource.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak saccade amplitude (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.