K08 VR Fear Conditioning

NCT07216222 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: IRB-24-60101K08MH138741-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Fear; PTSD; Veteran

Outcome Measures

Primary Outcomes (3)

• Intracranial EEG activity

  Power in the theta band (\~3-12 Hz).

  Baseline

• Skin conductance activity

  Electrodermal response during the fear conditioning experiment, as quantified by changes in electrical conductance between electrodes placed on the palm.

  Baseline

• Heart rate

  Baseline

Study Arms (1)

All RNS Participants

EXPERIMENTAL

In this single-arm study, all participants will complete identical experimental conditions with simultaneous iEEG recordings (Recording Study) or iEEG stimulation (Stimulation Study).

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

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

All RNS Participants

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- History of traumatic brain injury

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator
• Duke University: collaborator
• VA Greater Los Angeles Healthcare System: collaborator

Study Sites (1)

UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 14, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 28, 2030
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)