Emotional Memory, Fear, GAD, PTSD
Conditions
Brief summary
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.
Interventions
DEVICEDeep Brain Stimulation
Deep brain stimulation will be used
BEHAVIORALVirtual and augmented reality tasks
Virtual and augmented reality tasks will be used.
Sponsors
Duke University
National Institutes of Health (NIH)
VA Greater Los Angeles Healthcare System
NeuroPace
National Institute of Mental Health (NIMH)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement * Willing to provide informed consent and participate in the study * Ability to read and write English fluently
Exclusion criteria
* Unwilling to provide informed consent * Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement * Pregnant women * Participants with active psychosis * Participants with suicidal ideation * Participants with substance abuse issues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological change - eye-blinks | during the intervention/behavioral tasks with and without stimulation | Eye blinks will be measured using an eye tracking device and will be measure in blinks per second. |
| Physiological change - heart rate variability | during the intervention/behavioral tasks with and without stimulation | heart rate variability will be measured in milliseconds. |
| Physiological change - skin conductance | during the intervention/behavioral tasks with and without stimulation | Skin conductance will be measured in microSiemens. |
| Neurophysiological activity | during the intervention/behavioral tasks with and without stimulation | Neurophysiological activity will be measured in Hz |
Countries
United States
Contacts
CONTACTAaron Halvorsen, PhD
PRINCIPAL_INVESTIGATORNanthia Suthana, PhD
Duke Health
Outcome results
None listed