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Neurostimulation

Responsive Neurostimulation for PTSD

Verified Trial
Phase < 1
Recruiting
Research Sponsored by VA Greater Los Angeles Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male aged 25-60 years.
Male aged 25-60 years.
Timeline
Screening 7 weeks
Treatment 48 months
Follow Up 36 months
Awards & highlights

Study Summary

This trial will use a device to record electrical activity in the brain to detect patterns associated with PTSD, which will then be treated with electrical pulses in an attempt to improve symptoms.

Who is the study for?
This trial is for male veterans aged 25-60 with severe PTSD that hasn't improved after trying at least three different treatments, including medication and psychotherapy. They must have stable health conditions, be on consistent psychotropic medications for two months prior to the study, and live in Southern California for the first year of the trial.Check my eligibility
What is being tested?
The NeuroPace® RNS® System is being tested to see if it can help manage PTSD by recording brain signals related to fear and stress from the amygdala. When certain patterns are detected, it sends out electrical pulses aimed at reducing symptoms like flashbacks and nightmares.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from implant surgery, changes in mood or behavior due to electrical stimulation of the brain, headaches, infection risk at implant site, and possible interference with normal brain function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged between 25 and 60.

Timeline

Screening ~ 7 weeks
Treatment ~ 48 months
Follow Up ~36 months
This trial's timeline: 7 weeks for screening, 48 months for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alpha rhythm frequency (EEG)
Tomography, Optical Coherence
Region of Interest analysis (FDG PET)
+2 more
Secondary outcome measures
Attention, Processing Speed and Memory: Wechsler Adult Intelligence Scale IV (WAIS-IV)143 - Digit Span subtest, Trail Making Test A and B, Ruff Figural Fluency Test (RFFT), Brief Visual Memory Test - Revised (BVMT-R), California Verbal Learning Test
Brief Visual Memory Test
California Verbal Learning Test
+21 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: RNS groupExperimental Treatment1 Intervention
This study consists in only one arm. In this arm, the patients will undergo the placement of the RNS implant and the subsequent RNS programming to optimize the PTSD symptoms.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,267,025 Total Patients Enrolled
VA Greater Los Angeles Healthcare SystemLead Sponsor
51 Previous Clinical Trials
8,561 Total Patients Enrolled

Media Library

NeuroPace® RNS® System (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04152993 — Phase < 1
Post-Traumatic Stress Disorder Research Study Groups: RNS group
Post-Traumatic Stress Disorder Clinical Trial 2023: NeuroPace® RNS® System Highlights & Side Effects. Trial Name: NCT04152993 — Phase < 1
NeuroPace® RNS® System (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04152993 — Phase < 1
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04152993 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size of this trial?

"Affirmative. The clinicaltrials.gov portal reveals that this investigation is actively seeking patient enrolment, with 6 participants desired at one location since its inception on March 22nd 2021 and subsequent updates occurring as recently as July 5th 2022."

Answered by AI

What aims is this experiment hoping to achieve?

"The primary purpose of this medical trial, which should take approximately one year to complete, is to perform a Regional Interest Analysis (FDG PET). As part of the secondary objectives, investigators will employ tests such as Wechsler Adult Intelligence Scale IV (WAIS-IV)143 - Digit Span subtest, Trail Making Test A and B, Ruff Figural Fluency Test (RFFT), Brief Visual Memory Test - Revised (BVMT-R), California Verbal Learning Test along with Clinician Administered PTSD Scale and Wisconsin Card Sorting test in order to evaluate the safety and efficacy of BLA stimulation for treatment"

Answered by AI

Are participants of any age being enlisted for this research?

"As per the conditions of this medical trial, 25 is the minimum age for enrollment and 60 represents the maximum admission requirement."

Answered by AI

Are there any available openings for participants in this trial?

"That is correct. As per the information available on clinicaltrials.gov, this trial was initially posted on March 22nd 2021 and has been actively recruiting since then. Currently, 6 patients need to be sourced from one medical centre for inclusion in this research project."

Answered by AI

How may I submit my candidacy for this research experiment?

"This medical study is accepting 6 volunteers, all of whom must have PTSD and should be between the ages 25-60."

Answered by AI

Who else is applying?

What state do they live in?
Washington
Georgia
Other
California
How old are they?
18 - 65
What site did they apply to?
UCLA
VA Greater Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
0
1
3+

What questions have other patients asked about this trial?

What exactly does this trial entail? Duration of trial? Any restrictions (diet, nutrition) during trial?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

I've tried other drugs that don't help. I just would love to learn more about myself.
PatientReceived 2+ prior treatments
Interested in th study to relievers symptoms. I have been diagnosed depression and generalized anxiety and panic disorder I'm in Oklahoma I will relocate to get help.
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. UCLA: < 24 hours
  2. VA Greater Los Angeles: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Phone Call
~1 spots leftby May 2025