Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep Brain Stimulation, Virtual and augmented reality tasks.
- Who it may be relevant to
- Registry conditions: Fear, GAD, Emotional Memory, PTSD. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device Deep Brain Stimulation
Deep brain stimulation will be used - Behavioral Virtual and augmented reality tasks
Virtual and augmented reality tasks will be used.
Primary outcome measures
- Physiological change - eye-blinks [Time frame: during the intervention/behavioral tasks with and without stimulation]
- Physiological change - heart rate variability [Time frame: during the intervention/behavioral tasks with and without stimulation]
- Physiological change - skin conductance [Time frame: during the intervention/behavioral tasks with and without stimulation]
- Neurophysiological activity [Time frame: during the intervention/behavioral tasks with and without stimulation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- University of California Los Angeles — Los Angeles
- Duke University Health System — Durham
Identifiers
NCT: NCT05120635 · PRO00118015 · R01MH124761 · Pro00117931