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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 belowSelect...
I am a man aged between 25 and 60.
Timeline
Screening ~ 7 weeks1 visit
Treatment ~ 48 months1 visit
Follow Up ~ 36 months1 visit
Screening ~ 7 weeks
Treatment ~ 48 months
Follow Up ~36 months
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 moreSecondary 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 moreTrial 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
1,530 Previous Clinical Trials
10,264,702 Total Patients Enrolled
VA Greater Los Angeles Healthcare SystemLead Sponsor
51 Previous Clinical Trials
8,563 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have medical devices implanted in your brain, such as an aneurysm clip, shunt, cochlear implant or electrodes.If you started trauma-focused psychotherapy but had to stop because it was too difficult or caused too much emotional pain, you may still be able to participate in the study.My other health conditions have been stable for at least a year, and I don't use steroids or chemotherapy for them.I started a new psychotherapy program within the last 3 months.You have a medical condition that causes significant problems with your ability to think and remember.You have had problems with alcohol or illegal drugs in the past 6 months, or it may affect your ability to participate in the study.You cannot have taken any experimental drugs within the past month.The person has had a minimum baseline past month CAPS-5 score of 47, with full PTSD diagnostic criteria met, and scores of ≥ 3 on at least one item from the intrusive (CAPS-5 items 1-5) and hyperarousal (CAPS-5 Items 15-20) clustersI do not have any uncontrolled health issues like heart problems or diabetes.I completed PTSD therapy at least 3 months ago.You have attempted suicide in the past two years or have a plan to commit suicide.I have a brain condition affecting my blood vessels or other brain processes.I've been on the same mental health medication for 2 months and won't change it for 6 months, unless needed.If you started trauma-focused therapy but had to stop because it was too intense and caused more harm than good, you may be included in the study.I completed PTSD therapy over 3 months ago.I've tried at least 3 PTSD treatments including medication and therapy without success.I've tried at least 3 treatments for PTSD without success, including medication and therapy.I do not have major neurological conditions or serious head injuries affecting my participation.You have a weakened immune system.You have a mental health condition, such as unstable psychosis or bipolar disorder, that is not currently under control and may cause a risk for violence.You agree to tell the study doctors if you experience any unexpected mental or neurological symptoms.I am a man aged between 25 and 60.I suffer from chronic pain that is not well-managed.I have had brain surgery in the past.I am a man aged between 25 and 60.
Research Study Groups:
This trial has the following groups:- Group 1: RNS group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 7 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 48 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 36 Months after you stop receiving the treatment.
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
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+
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
I have been diagnosed depression and generalized anxiety and panic disorder I'm in Oklahoma I will relocate to get help.
PatientReceived 1 prior treatment
Ketamine was good but I only had 4 treatments. Gabapentin helps . All other Prozac , lexapro, Wellbutrin , abilify did not . Presently in talk therapy.
PatientReceived 2+ prior treatments
I have dealt with PTSD since 2013 and I would just like to get back to being who I was before the accident. I don’t really know who I am now please help.
PatientReceived 1 prior treatment
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
How responsive is this trial?
Most responsive sites:
- UCLA: < 24 hours
- VA Greater Los Angeles: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
Phone Call
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