Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

NCT06105892 | Recruiting DMC FDA Device

• 2 other identifiers: SQRL001W81XWH22C0146
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Convergence Insufficiency; Traumatic Brain Injury; Concussion, Mild

Keywords

Virtual Reality; Cross-Sectional; Therapy; Convergence Insufficiency; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Brain Injury Vision Symptom Survey

  Baseline (preintervention) and within 1 week after intervention

• Neurobehavioral Symptom Inventory

  Baseline (preintervention) and within 1 week after intervention

• Convergence Insufficiency Symptom Survey

  Baseline (preintervention) and within 1 week after intervention

Study Arms (4)

BNC Active

EXPERIMENTAL

Binocularly normal controls receiving active therapy

Device: Virtual Eye Rotation Vision Exercise (VERVE)

BNC Sham

SHAM COMPARATOR

Binocularly normal controls receiving sham therapy

Device: Sham VR Therapy

PTCI Active

EXPERIMENTAL

Post-traumatic Convergence Insufficiency participants receiving active therapy

Device: Virtual Eye Rotation Vision Exercise (VERVE)

PTCI Sham

SHAM COMPARATOR

Post-traumatic Convergence Insufficiency participants receiving sham therapy

Device: Sham VR Therapy

Interventions

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.

Also known as: Virtual Reality Vergence Exercises, Vergency Therapy

BNC Active; PTCI Active

Sham VR Therapy DEVICE

VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

BNC Sham; PTCI Sham

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• experienced less than 24 hours of post-traumatic amnesia (PTA), if any;
• 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);
• have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);
• 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;
• are fluent in English; and
• have been on stable doses of any vision-altering medications for the past 2 months.
• Stereopsis of 500 sec arc using Randot Stereo Test.
• Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
• Near point of convergence (NPC) \> 5 cm
• Convergence amplitude at near \< 15PD break or the Sheard criterion not met
• are aged 18 - 40;

You may not qualify if:

• 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;
• any condition that would prevent the participant from completing the protocol;
• appointment of a legal representative, to avoid coercion of a vulnerable population;
• any ongoing litigation related to TBI, to prevent interference with legal proceedings;
• membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
• Previous vergence therapy, orthoptics, home-based therapy, etc.
• Amblyopia or constant strabismus or strabismus surgery.
• High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia \>1.5PD difference between eyes; Prior refractive surgery.
• Manifest or latent nystagmus evident clinically.
• Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).

Sponsors & Collaborators

• New Jersey Institute of Technology: lead
• 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

Study Sites (1)

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

RECRUITING

MeSH Terms

Conditions

Ocular Motility Disorders; Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Cranial Nerve Diseases; Eye Diseases; Brain Injuries; Brain Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Study Officials

• Chang Yaramothu, PhD

  New Jersey Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Yaramothu, PhD

CONTACT

9736424844; cy53@njit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the clinical coordinators and technicians (programming the therapy) will know the therapy type. Investigators, clinical examiners, and data analysts, will be masked to therapy type until performing group level analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Each of these participant cohorts (Control and TBI with CI \[PTCI\]) will be randomly halved to generate a total of four cohorts for a semi-crossover study design: 1) BNC Active, 2) BNC Sham \[Placebo\], 3) PTCI Active, and 4) PTCI Sham \[control group\]. PTCI participants in Sham will later undergo active therapy.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 30, 2023
• Study Start: October 23, 2023
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: On an annual basis after the start of the study and at the conclusion of the study

Locations

US (1)