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NCT04152993 · ClinicalTrials.gov registry record · Early Phase 1
Responsive Neurostimulation for Post-Traumatic Stress Disorder
A Early Phase 1 study of Post Traumatic Stress Disorder, sponsored by VA Greater Los Angeles Healthcare System.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04152993 is a Early Phase 1 study of Post Traumatic Stress Disorder that is actively recruiting participants, run by VA Greater Los Angeles Healthcare System. The registered enrollment target is 6 participants, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04152993, a Early Phase 1 study of Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by VA Greater Los Angeles Healthcare System.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
Post-traumatic stress disorder (PTSD) refractory to treatment is marked by failure of fear extinction and its biological substrate, amygdala reactivity to trauma reminders. Decades of research have clarified the neuronal mechanisms coordinating fear extinction and consolidation. Fear cells and extinction cells in the basolateral amygdala (BLA) alter their firing rate based on the nature of the stimulus and the influence from the medial prefrontal cortex (mPFC) and the ventral hippocampus (vHPC). Together, the BLA, mPFC, and the vHPC form an anxiety-processing network where the BLA links stimulus to emotion, the vHPC provides memory context, and the mPFC coordinates extinction or consolidation. Local field potential (LFP) recordings from the BLA have revealed specific signals that correspond to an enhanced fear state. Previous studies have shown that neuromodulation of the BLA can promote extinction in a rodent model and in a treatment-refractory PTSD patient. This action is likely carried by disrupting fear signals within the BLA; however, continuous neurostimulation may also disrupt normal function of the amygdala. The present application proposes to investigate the use of Responsive Neurostimulation (RNS, Neuropace) in six (6) veterans suffering from severe treatment-resistant PTSD. This dual-activity device will allow us to chronically record LFPs from the BLA under specific conditions such as fear conditioning, exposure to trauma reminders, and emotional memory encoding and retrieval. In addition, the neural activity will be captured during real-life symptoms of flashback and nightmares. These recordings will provide the specific electrophysiological biomarkers of hypervigilance and re-experiencing. The device will then be programmed to detect and treat these biomarkers with a pre-determined electrical pulse. The patients will be followed prospectively using psychological scales but also with functional neuroimaging and electroencephalograms. These modalities wi
Conditions Studied
Interventions
- DEVICE NeuroPace® RNS® System
Study Locations (1)
California
- VA Greater Los Angeles - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-03-22 |
| Est. Completion | 2026-07-31 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04152993
The ClinicalTrials.gov registry entry for NCT04152993 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,117-participant average among 144 other Post Traumatic Stress Disorder trials with a reported enrollment target (99% lower). The listed sponsor is VA Greater Los Angeles Healthcare System, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which NeuroPace® RNS® System is the first listed.
NCT04152993 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04152993 about?
NCT04152993 is a clinical study titled "Responsive Neurostimulation for Post-Traumatic Stress Disorder". Post-traumatic stress disorder (PTSD) refractory to treatment is marked by failure of fear extinction and its biological substrate, amygdala reactivity to trauma reminders. Decades of research have clarified the neuronal mechanisms coordinating fear extinction and consolidation. Fear cells and extin...
What is the current status of trial NCT04152993?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 6 participants. The study started on 2021-03-22. Estimated completion is 2026-07-31.
What conditions does trial NCT04152993 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT04152993?
The interventions under investigation include: NeuroPace® RNS® System (DEVICE).
Who is sponsoring clinical trial NCT04152993?
This trial is sponsored by VA Greater Los Angeles Healthcare System, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04152993 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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