NCT06105892 · New Jersey Institute of Technology
Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
(iRAPID)
What this study is about
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 in an automated manner.
View original scientific description
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 in an automated manner. This research will involve 30 non-traumatic brain injury (TBI) binocularly normal (BNC) Veterans and 50 post-traumatic convergence insufficiency (PTCI) Veterans who will undergo Active and Sham therapy (equally divided groups) to determine the effectiveness of VERVE vergence therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Inclusion Criteria:
- 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 criteria
- 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).
Where
- Albuquerque, New Mexico
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations