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Deep Brain Stimulation for PTSD
Study Summary
This trial is testing a new therapy for PTSD that involves placing electrodes in specific areas of the brain. The hope is that by stimulating these areas, the symptoms of PTSD will be alleviated.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have a serious neurological condition or had a severe head injury.I do not have any uncontrolled medical conditions.I am not a good candidate for general anesthesia or deep brain stimulation surgery.I have tried specific medications for at least 3 months.I have been in psychotherapy twice a month for 6 months, with sessions lasting at least 45 minutes.I do not have psychosis, bipolar disorder, or a significant risk for violence.I started a new psychotherapy program within the last 3 months.I have chronic pain that is not well-managed.I am currently on blood thinners.I have not had electroconvulsive therapy in the last 6 months.My PTSD symptoms are severe, scoring at least 85 on the CAPS17.I live with my spouse or partner who meets certain health criteria.I haven't used any experimental drugs or psychotropic herbs in the last 30 days.I am on immunosuppressive therapy.I have had brain surgery or have specific implants in my body.I cannot stop my therapeutic diathermy treatment.I am a man between 25 and 70 years old.I have tried at least 2 antidepressants for 6 months without improvement.I have tried prazosin at 10 mg daily or the highest dose I can tolerate for at least 3 months.I've been on the same mental health medication for 2 months and agree not to change it for 6 months unless needed.My main mental health issue is severe PTSD that hasn't improved with treatment.My illness has lasted for at least 5 years without a 6-month break.I completed PTSD therapy at least 3 months ago.My PTSD significantly affects my social life.My other health conditions have been stable for at least a year.I have a brain condition affecting my blood vessels or other brain processes.My PTSD significantly affects my ability to work.
- Group 1: DBS of the Amygdala-30 days
- Group 2: DBS of the Amygdala-90 days
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Which demographic is most suitable for inclusion in this clinical research?
"This research study is recruiting 6 individuals with moral injury, aged between 25 and 70. In order to be eligible for selection, participants must comply with the following criteria: Presentation of PTSD as a primary psychiatric issue confirmed by a clinical interview and CAPS., Maleness in the range of 25-70 years old., Ability to provide informed consent under institutional policies while participating in two year follow up assessment which comprise stimulator adjustments., Demonstration of chronic treatment refractory PTSD that causes distress & obstructs social/occupational activities., Confirmation of combat trauma exposure through military record review and Combat Exposure Scale score above 9 points.. Minimum 5 year"
How many people are involved in this experimental research?
"Affirmative. The trial is still open to volunteers according to the clinicaltrials.gov listing, which was initially published on January 1st 2014 and last updated October 12th 2022. 6 participants are required for this single-site study."
Can individuals aged 50 or over participate in this clinical exploration?
"The prerequisites for this medical research involve a participant being between 25 to 70 years old. There are separate trials dedicated to children, with 46 studies for those below 18 and 328 specifically targeting patients over 65."
Is this study still accepting participants?
"Affirmative - the clinical trial is still in progress and recruiting patients. It was initially listed on January 1st 2014, with its latest update occurring October 12th 2022; 6 individuals are needed at one medical facility."
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