## Protocol Section
### Identification Module
**NCT ID:** NCT06417216

**Acronym:** OCNP

**Brief Title:** Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies

**Official Title:** Head-Cancelled Virtual Reality for Rehabilitation of Ocular Cranial Nerve Palsies

#### Organization Study ID Info
**ID:** 00001090
#### Organization
**Class:** OTHER
**Full Name:** University of Massachusetts, Worcester
### Status Module
#### Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** American Academy of Optometry

#### Lead Sponsor

**Class:** OTHER

**Name:** Kevin Houston

#### Responsible Party

**Investigator Affiliation:** University of Massachusetts, Worcester

**Investigator Full Name:** Kevin Houston

**Investigator Title:** Associate Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Internuclear Ophthalmoplegia

- Palsy, Abducens

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Study tasks performed in head-cancelled conditions

**Intervention Names:**

- Behavioral: Head-cancelled virtual reality

**Label:** Head Cancelled

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Study tasks performed in normal conditions.

**Label:** Normal

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Head Cancelled

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

**Name:** Head-cancelled virtual reality

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Maximum amplitude of eye movement

**Measure:** Peak saccade amplitude

**Time Frame:** 5 minutes

#### Secondary Outcomes

**Description:** Mean deviation of the head from the neutral position during each task

**Measure:** Mean head position

**Time Frame:** 5 minutes

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kevin.houston@umassmed.edu

**Name:** Kevin Houston, OD

**Phone:** 7744418745

**Role:** CONTACT

**Contact 2:**

**Email:** michelle.manxhari@umassmed.edu

**Name:** Michelle Manxhari, BS

**Phone:** 5089488122

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Worcester

**Contacts:**

***Contact 1:***

- **Email:** kevin.houston@umassmed.edu

- **Name:** Kevin Houston, OD

- **Phone:** 774-441-8745

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Massachusetts Chan Medical School

**State:** Massachusetts

**Status:** RECRUITING

**Zip:** 01605

#### Overall Officials

**Official 1:**

**Affiliation:** University of Massachusetts, Worcester

**Name:** Kevin E Houston, OD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010243

- Term: Paralysis

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000005128

- Term: Eye Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000013285

- Term: Strabismus

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC11

- Name: Eye Diseases

### Condition Browse Module - Browse Leaves

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M12817

- Name: Ophthalmoplegia

- Relevance: HIGH

- As Found: Ophthalmoplegia

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: HIGH

- As Found: Cranial Nerve Palsy

- ID: M18386

- Name: Ocular Motility Disorders

- Relevance: HIGH

- As Found: Internuclear Ophthalmoplegia

- ID: M22230

- Name: Abducens Nerve Diseases

- Relevance: HIGH

- As Found: Palsy, Abducens

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16075

- Name: Strabismus

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009886

- Term: Ophthalmoplegia

- ID: D000003389

- Term: Cranial Nerve Diseases

- ID: D000015835

- Term: Ocular Motility Disorders

- ID: D000020434

- Term: Abducens Nerve Diseases

### Misc Info Module

- Version Holder: 2024-05-31
