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

April 9, 2026 updated by: Chang Yaramothu, New Jersey Institute of Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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:
        • Contact:
        • Principal Investigator:
          • Billie C Pack, OD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Near Point of Convergence
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
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
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
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)
Time Frame: Baseline (preintervention) and within 1 week after intervention
measured in degress/second
Baseline (preintervention) and within 1 week after intervention
Objective Eye-Tracking Measures (Response Accuracy)
Time Frame: Baseline (preintervention) and within 1 week after intervention
measured as a percentage of response divided by target amplitude
Baseline (preintervention) and within 1 week after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain Injury Vision Symptom Survey
Time Frame: Baseline (preintervention) and within 1 week after intervention
Normal range is < 31 for adults
Baseline (preintervention) and within 1 week after intervention
Neurobehavioral Symptom Inventory
Time Frame: Baseline (preintervention) and within 1 week after intervention
Normal range is < 18 for adults
Baseline (preintervention) and within 1 week after intervention
Convergence Insufficiency Symptom Survey
Time Frame: Baseline (preintervention) and within 1 week after intervention
Normal range is < 21 for adults
Baseline (preintervention) and within 1 week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New Jersey Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Army Medical Research and Development Command
University of New Mexico
Biomedical Research Institute of New Mexico
New Mexico VA Healthcare System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chang Yaramothu, PhD, New Jersey Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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