Recruiting

VERVE

Sponsor:

New Jersey Institute of Technology

Code:

NCT06105892

Conditions

Convergence Insufficiency

Traumatic Brain Injury

Concussion, Mild

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Virtual Eye Rotation Vision Exercise (VERVE)

Sham VR Therapy

Study Details

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

Study ID

NCT06105892

Start date

Oct 23, 2023

Status verified date

Apr, 2026

Completion date

Sep 20, 2027

Anticipated

Primary completion date

Jun 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BNC Active

Binocularly normal controls receiving active therapy

sham comparator: BNC Sham

Binocularly normal controls receiving sham therapy

experimental: PTCI Active

Post-traumatic Convergence Insufficiency participants receiving active therapy

sham comparator: PTCI Sham

Post-traumatic Convergence Insufficiency participants receiving sham therapy

Interventions

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.

Sham VR Therapy

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

Primary outcome measure

  • 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 ]
  • 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 ]
  • Objective Eye-Tracking Measures (Peak Velocity) [ Time Frame: Baseline (preintervention) and within 1 week after intervention ]
  • Objective Eye-Tracking Measures (Response Accuracy) [ Time Frame: Baseline (preintervention) and within 1 week after intervention ]

Central Contacts and Locations

Central contacts

Chang Yaramothu, PhD

9736424844cy53@njit.edu

Locations

New Mexico VA Health Care System

Recruiting

Albuquerque, New Mexico, United States, 87108

Contacts

Principal Investigator:

Billie C Pack, OD

More Information

Sponsor

New Jersey Institute of Technology

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New Jersey Institute of Technology on 2026-04-14.