Status:
RECRUITING
Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
Lead Sponsor:
New Jersey Institute of Technology
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
University of New Mexico
Conditions:
Convergence Insufficiency
Traumatic Brain Injury
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
This study will test a portable virtual reality (VR) system with integrated eye tracking called Virtual Eye Rotation Vision Exercises (VERVE). The proposed VERVE platform will deliver vergence therapy...
Eligibility Criteria
Inclusion
- Mild Traumatic Brain Injury (mTBI) Cohort
- are aged 18 - 40;
- have suffered a mTBI according to VA/Department of Defense (DoD) criteria with documented evidence of alteration of consciousness (AOC) \< 24 hours or loss of consciousness (LOC) less than 30 minutes;
- were injured between 1 month and 15 years ago;
- received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;
- experienced less than 24 hours of post-traumatic amnesia (PTA), if any;
- have ongoing post-concussive symptoms as evidenced by a score of 18 or greater or a score of 2 or greater on question 6 (vision problems, blurring, trouble seeing) on the Neurobehavioral Symptom Inventory (NSI);
- have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);
- have PTCI as evidenced by obtaining a score of 21 or higher on the convergence insufficiency symptom survey (CISS), a specific measure of convergence insufficiency;
- are fluent in English; and
- have been on stable doses of any vision-altering medications for the past 2 months.
- Stereopsis of 500 sec arc using Randot Stereo Test.
- Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
- Near point of convergence (NPC) \> 5 cm
- Convergence amplitude at near \< 15PD break or the Sheard criterion not met
- Control
- are aged 18 - 40;
- CISS score of 20 or lower;
- near point of convergence (NPC) \< 6cm; and
- positive fusional range \>15 prism diopters.
- Stereopsis of 500 sec arc using Randot Stereo Test.
Exclusion
- prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
- history of psychosis, as there are known visual performance findings associated with psychosis;
- history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
- recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
- any condition that would prevent the participant from completing the protocol;
- appointment of a legal representative, to avoid coercion of a vulnerable population;
- any ongoing litigation related to TBI, to prevent interference with legal proceedings;
- membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
- Previous vergence therapy, orthoptics, home-based therapy, etc.
- Amblyopia or constant strabismus or strabismus surgery.
- High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia \>1.5PD difference between eyes; Prior refractive surgery.
- Manifest or latent nystagmus evident clinically.
- Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06105892
Start Date
October 23 2023
End Date
March 20 2027
Last Update
November 18 2024
Active Locations (1)
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1
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108