Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorNew Jersey Institute of Technology
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Virtual Eye Rotation Vision Exercise (VERVE)
- Sham VR Therapy
Treatment groups
100 Participants
are divided into 4 treatment groupsSponsors and collaborators
New Jersey Institute of Technology
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborator
University of New Mexico
Collaborator
Biomedical Research Institute of New Mexico
Collaborator
New Mexico VA Healthcare System
Collaborator
Source ClinicalTrials.gov