Eye Recovery Automation for Post Injury Dysfunction (iRAPID) (iRAPID)

Eye Recovery Automation for Post Injury Dysfunction

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Concussion, Mild; Convergence Insufficiency
• Intervention / Treatment: Device: Virtual Eye Rotation Vision Exercise (VERVE); Device: Sham VR Therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Yaramothu, PhD; Phone Number: 9736424844; Email: cy53@njit.edu

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • Recruiting
      • New Mexico VA Health Care System
      • Contact: Kelli Ober; Email: kelli.ober@va.gov
      • Contact: Tiana Maple; Email: tiana.maple@va.gov
      • Principal Investigator: Billie C Pack, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 specific measure of convergence insufficiency;
9. are fluent in English; and
10. have been on stable doses of any vision-altering medications for the past 2 months.
11. Stereopsis of 500 sec arc using Randot Stereo Test.
12. Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
13. Near point of convergence (NPC) > 5 cm
14. Convergence amplitude at near < 15PD break or the Sheard criterion not met

Control Inclusion Criteria:

1. are aged 18 - 40;
2. CISS score of 20 or lower;
3. near point of convergence (NPC) < 6cm; and
4. positive fusional range >15 prism diopters.
5. Stereopsis of 500 sec arc using Randot Stereo Test.

Exclusion Criteria:

1. prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
2. history of psychosis, as there are known visual performance findings associated with psychosis;
3. history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
4. recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
5. any condition that would prevent the participant from completing the protocol;
6. appointment of a legal representative, to avoid coercion of a vulnerable population;
7. any ongoing litigation related to TBI, to prevent interference with legal proceedings;
8. membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
9. Previous vergence therapy, orthoptics, home-based therapy, etc.
10. Amblyopia or constant strabismus or strabismus surgery.
11. High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia >1.5PD difference between eyes; Prior refractive surgery.
12. Manifest or latent nystagmus evident clinically.
13. Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BNC Active; Binocularly normal controls receiving active therapy	Device: Virtual Eye Rotation Vision Exercise (VERVE); 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.; Other Names: Virtual Reality Vergence Exercises; Vergency Therapy
Sham Comparator: BNC Sham; Binocularly normal controls receiving sham therapy	Device: Sham VR Therapy; VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.
Experimental: PTCI Active; Post-traumatic Convergence Insufficiency participants receiving active therapy	Device: Virtual Eye Rotation Vision Exercise (VERVE); 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.; Other Names: Virtual Reality Vergence Exercises; Vergency Therapy
Sham Comparator: PTCI Sham; Post-traumatic Convergence Insufficiency participants receiving sham therapy	Device: Sham VR Therapy; VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Point of Convergence	Normal range is < 6 cm	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	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
Objective Eye-Tracking Measures (Peak Velocity)	measured in degress/second	Baseline (preintervention) and within 1 week after intervention
Objective Eye-Tracking Measures (Response Accuracy)	measured as a percentage of response divided by target amplitude	Baseline (preintervention) and within 1 week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain Injury Vision Symptom Survey	Normal range is < 31 for adults	Baseline (preintervention) and within 1 week after intervention
Neurobehavioral Symptom Inventory	Normal range is < 18 for adults	Baseline (preintervention) and within 1 week after intervention
Convergence Insufficiency Symptom Survey	Normal range is < 21 for adults	Baseline (preintervention) and within 1 week after intervention

Collaborators and Investigators

• Sponsor: New Jersey Institute of Technology
• Collaborators: U.S. Army Medical Research and Development Command; University of New Mexico; Biomedical Research Institute of New Mexico; New Mexico VA Healthcare System
• Investigators: Principal Investigator: Chang Yaramothu, PhD, New Jersey Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): September 20, 2027

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Cross-Sectional; Therapy; Traumatic Brain Injury; Convergence Insufficiency
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Eye Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Cranial Nerve Diseases; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Ocular Motility Disorders
• Other Study ID Numbers: SQRL001; W81XWH22C0146 (Other Grant/Funding Number: U.S. Army Medical Research and Development Command)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data will be shared on Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR).
• IPD Sharing Time Frame: On an annual basis after the start of the study and at the conclusion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No