Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Unwilling to provide informed consent
Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement
Pregnant women
Participants with active psychosis
Trial design
Design model
Single group
Treatments tested in this trial
Deep Brain Stimulation
DeviceDeep brain stimulation will be used
Virtual and augmented reality tasks
BehavioralVirtual and augmented reality tasks will be used.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: EMU ParticipantsOther 2 interventions
Group B: RNS ParticipantsOther 2 interventions
Trial outcomes
Primary outcomes
1
Physiological change - eye-blinks
Eye blinks will be measured using an eye tracking device and will be measure in blinks per second.
Time frame
during the intervention/behavioral tasks with and without stimulation2
Physiological change - heart rate variability
heart rate variability will be measured in milliseconds.
Time frame
during the intervention/behavioral tasks with and without stimulation3
Physiological change - skin conductance
Skin conductance will be measured in microSiemens.
Time frame
during the intervention/behavioral tasks with and without stimulation4
Neurophysiological activity
Neurophysiological activity will be measured in Hz
Time frame
during the intervention/behavioral tasks with and without stimulationSponsors and contacts
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Duke University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
VA Greater Los Angeles Healthcare System
Collaborator
NeuroPace
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov