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Deep Brain Stimulation for PTSD
N/A
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
6 months of continuous individual psychotherapy, conducted at least twice monthly for minimum 45 minute sessions, with specific therapy types mentioned
Male aged 25-70 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
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.
Who is the study for?
This trial is for male veterans aged 25-70 with chronic, treatment-resistant PTSD from combat. They must have a stable medical condition and psychotropic medication use, cohabitate with someone who can report on their symptoms, and have tried multiple treatments without success. Excluded are those with certain implants, recent suicide attempts or substance abuse issues, significant cognitive impairments or other major psychiatric disorders.Check my eligibility
What is being tested?
The study tests Deep Brain Stimulation (DBS) of the Basolateral Nucleus of the Amygdala using Medtronic Activa PC DBS to alleviate PTSD symptoms. Participants will undergo electrode implantation in the brain and receive follow-up assessments and stimulator adjustments over two years.See study design
What are the potential side effects?
Potential side effects include unexpected neurological or psychiatric symptoms which participants agree to share with clinicians. There may also be risks associated with general anesthesia, surgery for electrode placement, and possible changes in brain function due to stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been in psychotherapy twice a month for 6 months, with sessions lasting at least 45 minutes.
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I am a man between 25 and 70 years old.
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My main mental health issue is severe PTSD that hasn't improved with treatment.
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My illness has lasted for at least 5 years without a 6-month break.
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I have tried at least 2 antidepressants for 6 months without improvement.
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I have tried prazosin at 10 mg daily or the highest dose I can tolerate for at least 3 months.
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My PTSD symptoms are severe, scoring at least 85 on the CAPS17.
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My PTSD significantly affects my ability to work.
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My PTSD significantly affects my social life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency and Severity of all adverse events
Secondary outcome measures
Clinician-Administered PTSD Scale
Trial Design
2Treatment groups
Experimental Treatment
Group I: DBS of the Amygdala-90 daysExperimental Treatment2 Interventions
Deep brain stimulation of the amygdala BLn starting at 90 days post-operatively.
Group II: DBS of the Amygdala-30 daysExperimental Treatment2 Interventions
Deep brain stimulation of the amygdala BLn starting at 30 days post-operatively.
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Who is running the clinical trial?
VA Greater Los Angeles Healthcare SystemLead Sponsor
51 Previous Clinical Trials
8,561 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: DBS of the Amygdala-30 days
- Group 2: DBS of the Amygdala-90 days
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 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.
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