[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548147":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":25,"studyPopulation":17,"armGroups":26,"interventions":37,"overallOfficials":43,"centralContacts":47,"locations":57,"responsibleParty":97,"collaborators":101,"id":104,"slug":17,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":17,"enrollmentInfo":114,"targetDuration":17,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":17,"overallStatus":60,"whyStopped":17,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Brooks Rehabilitation","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Peak saccade amplitude","Maximum amplitude of eye movement","5 minutes",[14],{"measure":15,"description":16,"timeFrame":12},"Mean head position","Mean deviation of the head from the neutral position during each task",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"RANDOMIZED","CROSSOVER","Subjects perform study tasks under head-active conditions, and then are crossed over to the head-cancelled condition.","TREATMENT",{"masking":24,"maskingDescription":17,"whoMasked":17},"NONE","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.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Head Cancelled","EXPERIMENTAL","Study tasks performed in head-cancelled conditions",[32],"Behavioral: Head-cancelled virtual reality",{"label":34,"type":35,"description":36,"interventionNames":17},"Normal","NO_INTERVENTION","Study tasks performed in normal conditions.",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":17},"BEHAVIORAL","Head-cancelled virtual reality","Scene in virtual reality moves with the head while performing visual tasks.",[28],[44],{"name":45,"affiliation":17,"role":46},"Kevin E Houston, OD","STUDY_DIRECTOR",[48,53],{"name":49,"role":50,"phone":51,"phoneExt":17,"email":52},"Kevin Houston, OD","CONTACT","508-753-5103","khouston@wsvisionsource.com",{"name":54,"role":50,"phone":55,"phoneExt":17,"email":56},"Shelli Levasseur, BS","5087535103","mlevasseur@wsvisionsource.com",[58,82],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Brooks Rehabilitation Hospital","RECRUITING","Jacksonville","Florida","32216","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-81.65565,30.33218,{"lat":70,"lon":69},[73,77,80],{"name":74,"role":50,"phone":75,"phoneExt":17,"email":76},"Hannah Grimes","904-345-7373","Hannah.Grimes@Brooksrehab.org",{"name":78,"role":50,"phone":75,"phoneExt":17,"email":79},"Katelyn Jordan, OD","katelyn.jordan@brooksrehab.org",{"name":78,"role":81,"phone":17,"phoneExt":17,"email":17},"PRINCIPAL_INVESTIGATOR",{"facility":83,"status":60,"city":84,"state":85,"zip":86,"country":64,"countryCode":65,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Vision Source of Worcester","Worcester","Massachusetts","01610",{"type":67,"coordinates":88},[89,90],-71.80229,42.26259,{"lat":90,"lon":89},[93,94,96],{"name":45,"role":50,"phone":51,"phoneExt":17,"email":52},{"name":95,"role":50,"phone":51,"phoneExt":17,"email":56},"Shelli Levasseur",{"name":45,"role":81,"phone":17,"phoneExt":17,"email":17},{"type":98,"investigatorFullName":99,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"SPONSOR_INVESTIGATOR","Kevin Houston","Investigator",[102],{"name":103,"class":6},"American Academy of Optometry","100548147",false,"NCT06417216","Head-Cancelled Virtual Reality for Ocular Cranial Nerve Palsies","Head-Cancelled Virtual Reality for Rehabilitation of Ocular Cranial Nerve Palsies","OCNP","OCNP Group Inclusion Criteria:\n\n* Presence of OCNP in one eye with 50% range-of-motion limitation or worse\n* Able to provide informed consent and will be able to fluently read and understand spoken English\n\nOCNP Group Exclusion Criteria:\n\n* Presence of bilateral OCNP\n* Range of motion better than 50%\n* Visual acuity worse than 20\u002F100 in either eye\n* Greater than 4-line difference in visual acuity between the eyes,\n* Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset\n\nParticipants will be excluded if they are unable to participate if inclusion criteria are not met.\n\nNormal Group Inclusion Criteria:\n\n* Absence of OCNP or other neurological or neuro-ophthalmic diseases\n* No strabismus\n* Have normal or near-normal vision with glasses or contact lenses.\n* Be able to provide informed consent and will be able to fluently read and understand spoken English\n\nNormal Group Exclusion Criteria:\n\n* Visual acuity worse than 20\u002F100 in either eye\n* Greater than 4-line difference in visual acuity between the eyes\n* Structural anomalies or sensory sensitivities (e.g. visual motion sensitivity) that would prevent them from wearing or tolerating a VR headset\n* Known inability to tolerate visual testing of at least 20 minutes continuously.",true,"ALL","18 Years",{"count":115,"type":116},40,"ESTIMATED","INTERVENTIONAL",[119],"NA","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.",[122,123],"Internuclear Ophthalmoplegia","Palsy, Abducens","2026-04-01",{"date":126,"type":127},"2026-04-06","ACTUAL",{"date":129,"type":127},"2024-09-10",{"date":131,"type":116},"2028-06-01",{"name":99,"class":6},2]