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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 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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Greater Los Angeles Healthcare SystemLead Sponsor

51 Previous Clinical Trials

8,563 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI