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Recruiting NCT06105892

Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Trial Parameters

Condition Convergence Insufficiency
Sponsor New Jersey Institute of Technology
Study Type INTERVENTIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age 40 Years
Start Date 2023-10-23
Completion 2026-09-20
Interventions
Virtual Eye Rotation Vision Exercise (VERVE)Sham VR Therapy

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 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.

Eligibility Criteria

Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria: 1. are aged 18 - 40; 2. 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; 3. were injured between 1 month and 15 years ago; 4. received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available; 5. experienced less than 24 hours of post-traumatic amnesia (PTA), if any; 6. 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); 7. have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS); 8. have PTCI as evidenced by obtaining a score of 21 or higher on the convergence insufficiency symptom survey (CISS), a

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