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K08 VR Fear Conditioning

Intracranial Recording and Stimulation of the Human Hippocampal-Amygdala Circuit During Virtual Reality Fear Conditioning

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07216222
Enrollment
70
Registered
2025-10-14
Start date
2025-03-01
Completion date
2030-02-28
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and Fear, PTSD, Veteran

Brief summary

The goal of this clinical trial is to learn how people respond to fear-related experiences in a virtual reality (VR) environment. The study will also look at how brain activity and body responses are connected to learning and memory of fear. To do so, we recruit individuals who are already implanted with a Responsive Neurostimulator (RNS) device for the treatment of epilepsy. This research may help improve our understanding of anxiety disorders and how to better treat them in the future. 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.

Interventions

DEVICEDeep Brain Stimulation

Deep brain stimulation via the Responsive Neurostimulator (RNS) device.

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Duke University
CollaboratorOTHER
VA Greater Los Angeles Healthcare System
CollaboratorFED
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Male * 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

\- History of traumatic brain injury

Design outcomes

Primary

MeasureTime frameDescription
Intracranial EEG activityBaselinePower in the theta band (\ 3-12 Hz).
Skin conductance activityBaselineElectrodermal response during the fear conditioning experiment, as quantified by changes in electrical conductance between electrodes placed on the palm.
Heart rateBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026