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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH124761 | U.S. NIH Grant/Contract | View source | |
| Pro00117931 | Other Identifier | Duke University |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| VA Greater Los Angeles Healthcare System | FED |
| NeuroPace | INDUSTRY |
| National Institute of Mental Health (NIMH) |
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Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.
The purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMU Participants | Other | Subjects participating in the study at the Epilepsy Monitoring Unity (EMU). |
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| RNS Participants | Other | Subjects with RNS implants. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Deep brain stimulation will be used |
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| Measure | Description | Time Frame |
|---|---|---|
| Physiological change - eye-blinks | Eye blinks will be measured using an eye tracking device and will be measure in blinks per second. | during the intervention/behavioral tasks with and without stimulation |
| Physiological change - heart rate variability | heart rate variability will be measured in milliseconds. | during the intervention/behavioral tasks with and without stimulation |
| Physiological change - skin conductance | Skin conductance will be measured in microSiemens. | during the intervention/behavioral tasks with and without stimulation |
| Neurophysiological activity | Neurophysiological activity will be measured in Hz | during the intervention/behavioral tasks with and without stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Vilchez | Contact | 9196812577 | suthanalab@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nanthia Suthana, PhD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Recruiting | Los Angeles | California | 90024 | United States |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| NIH |
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| Virtual and augmented reality tasks | Behavioral | Virtual and augmented reality tasks will be used. |
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| Duke University Health System | Recruiting | Durham | North Carolina | 27705 | United States |
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