Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

ConditionsConvergence Insufficiency Traumatic Brain Injury Concussion, Mild

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Virtual Eye Rotation Vision Exercise (VERVE)
Device
VERVE utilizes a virtual reality (VR) headset with integrated eye-tracking where the patient makes specific vergence eye movements by playing a VR game controlled by eye movements. Participants will be making convergence and divergence eye movements as steps and ramps.
Sham VR Therapy
Device
VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Treatment groups

100 Participants

are divided into 4 treatment groups

Group A: BNC ActiveExperimental treatment 1 intervention

Group B: BNC ShamSham comparator 1 intervention

Group C: PTCI ActiveExperimental treatment 1 intervention

Group D: PTCI ShamSham comparator 1 intervention

Trial outcomes

Primary outcomes

Near Point of Convergence

Normal range is \< 6 cm

Time frame

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

Positive Fusional Vergence

Normal range is \>15 Prism Diopters

Time frame

Objective Eye-Tracking Measures (Peak Velocity)

measured in degress/second

Time frame