K08 VR Fear Conditioning

University of California, Los Angeles (UCLA)

Status: Invitation-only

Conditions: PTSD; Anxiety and Fear; Veteran

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; NIH

Identifiers

NCT07216222

IRB-24-6010

1K08MH138741-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

All RNS Participants

Experimental group

Description:

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

Treatment:

Device: Deep Brain Stimulation