Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
70 participants
INTERVENTIONAL
2025-03-01
2030-02-28
Brief Summary
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The main questions it aims to answer are: 1) How do people learn to associate certain cues in VR with feelings of fear or safety? 2) What brain and body responses happen during fear learning?
Participants will: 1) Wear a virtual reality headset and experience different environments and sounds, 2) Have their brain activity, heart rate, and sweating measured, and 3) Receive safe, mild electrical pulses through the RNS device during the study to help study fear learning. Participants will attend one or more study sessions, each lasting about 3-4 hours.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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All RNS Participants
In this single-arm study, all participants will complete identical experimental conditions with simultaneous iEEG recordings (Recording Study) or iEEG stimulation (Stimulation Study).
Deep Brain Stimulation
Deep brain stimulation via the Responsive Neurostimulator (RNS) device.
Interventions
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Deep Brain Stimulation
Deep brain stimulation via the Responsive Neurostimulator (RNS) device.
Eligibility Criteria
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Inclusion Criteria
* Female
* Between 18 and 70 years of age
* Adequate visual and auditory acuity to allow neuropsychological testing
* Have undergone surgical placement of NeuroPace RNS System for the treatment of epilepsy or post-traumatic stress disorder
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
VA Greater Los Angeles Healthcare System
FED
University of California, Los Angeles
OTHER
Responsible Party
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Anthony Jang, MD
Principal Investigator
Locations
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UCLA Semel Institute for Neuroscience and Human Behavior
Los Angeles, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB-24-6010
Identifier Type: -
Identifier Source: org_study_id
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