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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

Must not have

Current significant neurological conditions or history of serious head injury with loss of consciousness

Uncontrolled medical conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious neurological condition or had a severe head injury.

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I do not have any uncontrolled medical conditions.

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I am not a good candidate for general anesthesia or deep brain stimulation surgery.

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I do not have psychosis, bipolar disorder, or a significant risk for violence.

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I have chronic pain that is not well-managed.

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I am currently on blood thinners.

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I am on immunosuppressive therapy.

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I have had brain surgery or have specific implants in my body.

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I cannot stop my therapeutic diathermy treatment.

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I have a brain condition affecting my blood vessels or other brain processes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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.

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Greater Los Angeles Healthcare SystemLead Sponsor

51 Previous Clinical Trials

8,561 Total Patients Enrolled

Media Library

DBS of the Basolateral Nucleus of the Amygdala Clinical Trial Eligibility Overview. Trial Name: NCT02091843 — N/A

Post-Traumatic Stress Disorder Research Study Groups: DBS of the Amygdala-30 days, DBS of the Amygdala-90 days

Post-Traumatic Stress Disorder Clinical Trial 2023: DBS of the Basolateral Nucleus of the Amygdala Highlights & Side Effects. Trial Name: NCT02091843 — N/A

DBS of the Basolateral Nucleus of the Amygdala 2023 Treatment Timeline for Medical Study. Trial Name: NCT02091843 — N/A

~0 spots leftby Dec 2024

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