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 range18 Years – 40 Years
SexALL
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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;
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
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