Automated virtual reality therapy for eye recovery after brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests a portable virtual reality system called Virtual Eye Rotation Vision Exercises (VERVE) designed to deliver automated vergence therapy for individuals with post-traumatic convergence insufficiency and mild traumatic brain injury. It will involve 80 Veterans, including those with normal binocular vision and those with post-traumatic symptoms, who will be randomly assigned to receive either active or sham therapy. The goal is to evaluate the effectiveness of the VERVE platform in improving vision-related symptoms associated with these conditions.

Why it matters

Who can join: the full rules

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).

Where it's running

• New Mexico VA Health Care System
  Albuquerque, New Mexico, United States Recruiting

Study contacts

• Principal investigator: Chang Yaramothu, PhD — New Jersey Institute of Technology
• Study coordinator: Chang Yaramothu, PhD
• Email: cy53@njit.edu
• Phone: 9736424844

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PIONEER-Prognosis: Using biomarkers and wearables to forecast recovery after mild traumatic brain injury

  This study tests whether blood biomarkers, health data from records, and wearables can help predict how people recover after a mild traumatic brain injury treated in the emergency department.

  Recruiting at 3 sites University of Michigan · Torrance, California and 4 other locations · NCT07858266

• HBOT to see if it helps cognition and well‑being in first responders with prior brain injury

  This study tests whether 40 hyperbaric oxygen therapy sessions can improve thinking skills and post-concussion symptoms in current or former first responders with a history of brain injury.

  Recruiting Phase 2 Summit Hyperbarics and Wellness · Boise, Idaho · NCT07852728

• Depth Electrode Monitoring after Traumatic Brain Injury

  This study tests adding a depth electrode with continuous brain monitoring during external ventricular drain placement in adults with traumatic brain injury to see if cortical reverberation signals can be tracked safely.

  Recruiting Hennepin Healthcare Research Institute · Minneapolis, Minnesota · NCT07842458

• Understanding growth hormone deficiency after a brain injury in adults

  This observational study tests whether growth hormone deficiency affects quality of life and symptoms in adults with traumatic brain injury and whether GH replacement helps after 12 weeks.

  Recruiting University of Calgary · Calgary, Alberta and 1 other locations · NCT07795736

• Electrical stimulation-assisted exercise for people with lower limb paralysis

  This study tests whether adding electrical stimulation during exercise can improve leg muscle strength and endurance for people with paralysis.

  Recruiting Louis Stokes VA Medical Center · Cleveland, Ohio · NCT07768761

• ZEPU-2000 robotic rehab for arm and leg weakness

  This trial tests whether adding ZEPU-2000A, ZEPU-2000D, and ZEPU-2000E robotic rehabilitation to usual therapy helps adults with arm/leg movement problems from stroke, incomplete SCI, TBI, or related conditions.

  Recruiting Bangladesh Medical University · Dhaka · NCT07749612

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.