Responsive Neurostimulation for PTSD
This study is looking at a new way to treat Post-Traumatic Stress Disorder (PTSD) that hasn't responded to other treatments. It uses a device called the NeuroPace® RNS® System. This device is surgically implanted in the brain, specifically in areas called the amygdala and hippocampus, which are involved in fear and memory. Researchers want to see if this device can change brain activity patterns (called spectral power analysis and oscillatory properties, and cross-frequency coupling) in people with PTSD. The study is currently unclear on its status and plans to enroll 6 men, aged 25-60, who are stable on their current PTSD medications. Participants will be followed for an average of 1 year to see how their brain activity changes.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 6 male participants.
- What's involved
- You would need to be stable on your current psychotropic medication for 2 months before the surgery and agree not to change your medication during the study. You would also participate in assessments and stimulator adjustments for 4 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for an average of 1 year to measure brain activity changes, and for 4 years for assessments and stimulator adjustments.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Responsive Neurostimulation for Post-Traumatic Stress Disorder
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Spectral power analysis and oscillatory propertiesBaseline
This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be Better Oscillation Detection (BOSC)
- Spectral power analysis and oscillatory propertiesthrough study completion, an average of 1 year
This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be Better Oscillation Detection (BOSC)
- Cross-frequency coupling and power coherence comodulogramsBaseline
This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be modulation index.
- Cross-frequency coupling and power coherence comodulogramsthrough study completion, an average of 1 year
This is associated with Specific Aim 1: To determine electrophysiological biomarkers of fear, extinction and PTSD symptoms. The metric for measurement will be modulation index.
- Region of Interest analysis (FDG PET)Baseline
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be Cerebral metabolic rate of glucose (CMRglc)
- Region of Interest analysis (FDG PET)After initial exposure session
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be Cerebral metabolic rate of glucose (CMRglc)
- Region of Interest analysis (FDG PET)12 months post-operatively
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be Cerebral metabolic rate of glucose (CMRglc)
- Alpha rhythm frequency (EEG)Baseline
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be frequency (Hertz)
- Alpha rhythm frequency (EEG)monthly after implantation for the first year
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be frequency (Hertz)
- Alpha rhythm frequency (EEG)quarterly during year 2-4
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be frequency (Hertz)
- Source localization (EEG)Baseline
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be discrete dipole fitting.
- Source localization (EEG)through study completion, an average of 1 year
This is associated with Specific Aim 2: To determine engagement of fear processing neural networks by neurostimulation. The metric for measurement will be discrete dipole fitting.