Eye Recovery Automation for Post Injury Dysfunction (iRAPID) (NCT06105892) | Clinical Trial Compass
RecruitingNot Applicable
Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
United States100 participantsStarted 2023-10-23
Plain-language 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 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
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Near Point of Convergence
Timeframe: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
2
Positive Fusional Vergence
Timeframe: Baseline (preintervention), within 1 week after session 4 of intervention, within 1 week after session 8 of intervention, within 1 week after session 12 of intervention, and within 1 week after intervention
3
Objective Eye-Tracking Measures (Peak Velocity)
Timeframe: Baseline (preintervention) and within 1 week after intervention
. 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;
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.