RECRUITING

Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Eye Recovery Automation for Post Injury Dysfunction

Quick Facts

Study Start:2023-10-23

Study Completion:2027-03-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06105892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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).

Inclusion Criteria

Exclusion 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

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).

Contacts and Locations

Study Contact

Chang Yaramothu, PhD

CONTACT

9736424844

cy53@njit.edu

Principal Investigator

Chang Yaramothu, PhD

PRINCIPAL_INVESTIGATOR

New Jersey Institute of Technology

Study Locations (Sites)

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108

United States

Collaborators and Investigators

Sponsor: New Jersey Institute of Technology

Chang Yaramothu, PhD, PRINCIPAL_INVESTIGATOR, New Jersey Institute of Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-23

Study Completion Date2027-03-20

Study Record Updates

Study Start Date2023-10-23

Study Completion Date2027-03-20

Terms related to this study

Keywords Provided by Researchers

Virtual Reality
Cross-Sectional
Therapy
Convergence Insufficiency
Traumatic Brain Injury

Additional Relevant MeSH Terms

Convergence Insufficiency
Traumatic Brain Injury
Concussion, Mild