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Enrolling by invitation NCT07216222

K08 VR Fear Conditioning

No phase Interventional Anxiety and Fear PTSD Veteran

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation.
Who it may be relevant to
Registry conditions: Anxiety and Fear, PTSD, Veteran. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Device Deep Brain Stimulation
    Deep brain stimulation via the Responsive Neurostimulator (RNS) device.

Primary outcome measures

  • Intracranial EEG activity [Time frame: Baseline]
  • Skin conductance activity [Time frame: Baseline]
  • Heart rate [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • UCLA Semel Institute for Neuroscience and Human Behavior — Los Angeles

Identifiers

NCT: NCT07216222 · IRB-24-6010 · 1K08MH138741-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗