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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH22C0146 | Other Grant/Funding Number | U.S. Army Medical Research and Development Command |
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| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
| University of New Mexico | OTHER |
| Biomedical Research Institute of New Mexico | OTHER |
| New Mexico VA Healthcare System |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNC Active | Experimental | Binocularly normal controls receiving active therapy |
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| BNC Sham | Sham Comparator | Binocularly normal controls receiving sham therapy |
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| PTCI Active | Experimental | Post-traumatic Convergence Insufficiency participants receiving active therapy |
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| PTCI Sham | Sham Comparator | Post-traumatic Convergence Insufficiency participants receiving sham therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Eye Rotation Vision Exercise (VERVE) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Near Point of Convergence | Normal range is < 6 cm | 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 | Normal range is >15 Prism Diopters | 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) | measured in degress/second | Baseline (preintervention) and within 1 week after intervention |
| Objective Eye-Tracking Measures (Response Accuracy) | measured as a percentage of response divided by target amplitude | Baseline (preintervention) and within 1 week after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Brain Injury Vision Symptom Survey | Normal range is < 31 for adults | Baseline (preintervention) and within 1 week after intervention |
| Neurobehavioral Symptom Inventory | Normal range is < 18 for adults |
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Mild Traumatic Brain Injury (mTBI) Cohort Inclusion Criteria:
Control Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Yaramothu, PhD | Contact | 9736424844 | cy53@njit.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chang Yaramothu, PhD | New Jersey Institute of Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Mexico VA Health Care System | Recruiting | Albuquerque | New Mexico | 87108 | United States |
Deidentified data will be shared on Federal Interagency Traumatic Brain Injury Research Informatics System (FITBIR).
On an annual basis after the start of the study and at the conclusion of the study
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| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
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| FED |
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.
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Only the clinical coordinators and technicians (programming the therapy) will know the therapy type. Investigators, clinical examiners, and data analysts, will be masked to therapy type until performing group level analysis.
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| Sham VR Therapy | Device | VERVE game without changes in eye movement demands. Maximizing gameplay with no intervention. |
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| Baseline (preintervention) and within 1 week after intervention |
| Convergence Insufficiency Symptom Survey | Normal range is < 21 for adults | Baseline (preintervention) and within 1 week after intervention |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |