Clinical trial NCT06105892: Eye Recovery Automation for Post Injury Dysfunction (iRAPID)
Official title: Eye Recovery Automation for Post Injury Dysfunction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Convergence Insufficiency
Traumatic Brain Injury
Concussion, Mild
Keywords: Virtual Reality
Cross-Sectional
Therapy
Convergence Insufficiency
Traumatic Brain Injury
Lead sponsor: New Jersey Institute of Technology
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
name: University of New Mexico
name: Biomedical Research Institute of New Mexico
name: New Mexico VA Healthcare System
First posted: 2023-10-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Near Point of Convergence
timeFrame: 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
measure: Positive Fusional Vergence
timeFrame: 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
measure: Objective Eye-Tracking Measures (Peak Velocity)
timeFrame: Baseline (preintervention) and within 1 week after intervention
measure: Objective Eye-Tracking Measures (Response Accuracy)
timeFrame: Baseline (preintervention) and within 1 week after intervention
Secondary outcomes:
measure: Brain Injury Vision Symptom Survey
timeFrame: Baseline (preintervention) and within 1 week after intervention
measure: Neurobehavioral Symptom Inventory
timeFrame: Baseline (preintervention) and within 1 week after intervention
measure: Convergence Insufficiency Symptom Survey
timeFrame: Baseline (preintervention) and within 1 week after intervention
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System
state: New Mexico
Study officials:
affiliation: New Jersey Institute of Technology
name: Chang Yaramothu, PhD
role: PRINCIPAL_INVESTIGATOR
References: