Eye Recovery Automation for Post Injury Dysfunction (iRAPID)

Официальное название

Eye Recovery Automation for Post Injury Dysfunction

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство Sham VR Therapy
  VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention.

Первичные конечные точки

• Near Point of Convergence [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline (preintervention) and within 1 week after intervention]
• Objective Eye-Tracking Measures (Response Accuracy) [Срок оценки: Baseline (preintervention) and within 1 week after intervention]

Вторичные конечные точки (3)

• Brain Injury Vision Symptom Survey [Срок оценки: Baseline (preintervention) and within 1 week after intervention]
• Neurobehavioral Symptom Inventory [Срок оценки: Baseline (preintervention) and within 1 week after intervention]
• Convergence Insufficiency Symptom Survey [Срок оценки: Baseline (preintervention) and within 1 week after intervention]

Критерии участия

Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria:

• are aged 18 - 40;
• 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;
• were injured between 1 month and 15 years ago;
• received a Glasgow coma scale (GCS) score of between 13 and 15 upon emergency department (ED) admission, if available;
• experienced less than 24 hours of post-traumatic amnesia (PTA), if any;
• 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);
• have ongoing vision-related symptoms as evidenced by a score of 31 or higher on the Brain Injury Vision Symptom Survey (BIVSS);
• 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;
• are fluent in English; and
• have been on stable doses of any vision-altering medications for the past 2 months.
• Stereopsis of 500 sec arc using Randot Stereo Test.
• Exophoria at near 4 prism-diopter (PD) or greater than magnitude at distance
• Near point of convergence (NPC) > 5 cm
• Convergence amplitude at near < 15PD break or the Sheard criterion not met

Control Inclusion Criteria:

• are aged 18 - 40;
• CISS score of 20 or lower;
• near point of convergence (NPC) < 6cm; and
• positive fusional range >15 prism diopters.
• Stereopsis of 500 sec arc using Randot Stereo Test.

Критерии исключения

• prior history of other neurological diseases, so as to reduce the risk of confounding effects on vision;
• history of psychosis, as there are known visual performance findings associated with psychosis;
• history of current or recent (within two years) substance/alcohol dependence, to reduce confounding effects on visual function
• recent medical hospitalization (within three weeks), to reduce risk of rehospitalization during the study;
• any condition that would prevent the participant from completing the protocol;
• appointment of a legal representative, to avoid coercion of a vulnerable population;
• any ongoing litigation related to TBI, to prevent interference with legal proceedings;
• membership in an identified vulnerable population, including minors and prisoners, so as to prevent coercion.
• Previous vergence therapy, orthoptics, home-based therapy, etc.
• Amblyopia or constant strabismus or strabismus surgery.
• High refractive error: Myopia ≥ 6.0PD sphere; Hyperopia ≥ 5.0PD sphere; Astigmatism ≥ 4.0PD; Anisometropia >1.5PD difference between eyes; Prior refractive surgery.
• Manifest or latent nystagmus evident clinically.
• Systemic diseases that affect accommodation, vergence, or ocular motility (i.e. multiple sclerosis, Graves' thyroid disease, myasthenia gravis, diabetes, chemotherapy or Parkinson disease).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• New Mexico VA Health Care System — Albuquerque

Идентификаторы

NCT: NCT06105892 · SQRL001 · W81XWH22C0146

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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