K08 VR Fear Conditioning

NCT ID: NCT07216222

Last Updated: 2025-10-14

Study Results

Results pending

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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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2030-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Anxiety and Fear PTSD Veteran

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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).

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

VA Greater Los Angeles Healthcare System

FED

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Anthony Jang, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCLA Semel Institute for Neuroscience and Human Behavior

Los Angeles, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1K08MH138741-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-24-6010

Identifier Type: -

Identifier Source: org_study_id

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