What side effects are associated with this type of intervention?

Common treatments for PTSD that involve neuromodulation, such as Responsive Neurostimulation (RNS), can have side effects including lightheadedness, tingling, and tinnitus. Invasive procedures like deep brain stimulation (DBS) may cause more severe side effects such as infection, hemorrhage, confusion, or seizures, though these are less common. Non-invasive methods like transcranial magnetic stimulation (TMS) typically have fewer and milder side effects, such as mild discomfort at the stimulation site.

What prior FDA approvals exist?

The FDA has approved several treatments for Post-Traumatic Stress Disorder (PTSD), primarily focusing on pharmacological options such as selective serotonin reuptake inhibitors (SSRIs) like sertraline and paroxetine. However, treatments similar to Responsive Neurostimulation (RNS), which targets fear signals in the basolateral amygdala, are still largely in the experimental stage. Neuromodulation techniques, such as transcranial magnetic stimulation (TMS), have shown promise in clinical trials but are not yet widely approved specifically for PTSD. These treatments aim to modulate neural circuits involved in fear and anxiety, similar to the mechanism of RNS.

What other types of research exist?

Promising, novel alternatives to Responsive Neurostimulation (RNS) for PTSD treatment include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in treating depression and may be useful for PTSD by modulating brain activity. 2) Vagus Nerve Stimulation (VNS), which has been explored for its potential to reduce symptoms in treatment-resistant depression and may have applications in PTSD. 3) Cranial Electrotherapy Stimulation (CES), which has shown safety and efficacy in treating depression and anxiety, conditions often comorbid with PTSD.

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Neurostimulation

Responsive Neurostimulation for PTSD

Q: What is the mechanism of action of this treatment?

Post-Traumatic Stress Disorder (PTSD) treatments often target the neurobiological mechanisms underlying fear and anxiety. Responsive Neurostimulation (RNS) disrupts fear signals in the basolateral amygdala, promoting fear extinction by modulating neural activity associated with trauma reminders. This is crucial for PTSD patients as it directly addresses the heightened fear response and helps in reducing symptoms. Similarly, SSRIs (Selective Serotonin Reuptake Inhibitors) increase serotonin levels in the brain, which can improve mood and reduce anxiety. Trauma-focused Cognitive Behavioral Therapy (CBT) helps patients process traumatic memories and reduce avoidance behaviors through exposure and cognitive restructuring. These treatments are essential as they address both the biological and psychological aspects of PTSD, providing a comprehensive approach to symptom management.

Verified Trial

Phase < 1

Waitlist Available

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.

Timeline

Screening 7 weeks

Treatment 48 months

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a device called Responsive Neurostimulation (RNS) to help veterans with severe PTSD who haven't responded to other treatments. The device records brain activity and sends electrical pulses to reduce fear and trauma responses. This approach aims to improve PTSD symptoms by targeting the brain's fear processing mechanisms.

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.

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.

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 weeks1 visit

Treatment ~ 48 months1 visit

Follow Up ~ 36 months1 visit

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Alpha rhythm frequency (EEG)

Tomography, Optical Coherence

Region of Interest analysis (FDG PET)

+2 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Post-Traumatic Stress Disorder (PTSD) treatments often target the neurobiological mechanisms underlying fear and anxiety. Responsive Neurostimulation (RNS) disrupts fear signals in the basolateral amygdala, promoting fear extinction by modulating neural activity associated with trauma reminders. This is crucial for PTSD patients as it directly addresses the heightened fear response and helps in reducing symptoms. Similarly, SSRIs (Selective Serotonin Reuptake Inhibitors) increase serotonin levels in the brain, which can improve mood and reduce anxiety. Trauma-focused Cognitive Behavioral Therapy (CBT) helps patients process traumatic memories and reduce avoidance behaviors through exposure and cognitive restructuring. These treatments are essential as they address both the biological and psychological aspects of PTSD, providing a comprehensive approach to symptom management.

PTSD: from neurobiology to pharmacological treatments.