Automated virtual reality therapy for eye recovery after brain injury

Eye Recovery Automation for Post Injury Dysfunction

This study tests a new virtual reality therapy to see if it can help veterans with vision problems after a brain injury feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 40 Years
• Sex: All
• Sponsor: New Jersey Institute of Technology (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Albuquerque, New Mexico)
• Trial ID: NCT06105892 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Veterans aged 18-40 who have experienced a mild traumatic brain injury and have ongoing vision-related symptoms.

Not a fit: Patients with severe traumatic brain injuries or those who do not exhibit convergence insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly improve vision recovery and quality of life for patients suffering from post-traumatic eye dysfunction.

How similar studies have performed: While the use of virtual reality in therapy is gaining traction, this specific automated approach for eye recovery is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Albuquerque, New Mexico

• 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

Conditions Convergence Insufficiency; Traumatic Brain Injury; Concussion, Mild; Virtual Reality; Cross-Sectional; Therapy