Deep Brain Stimulation for Post-Traumatic Stress Disorder

Phase 1

Recruiting

Led By Nir Lipsman, MD PhD

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5)

Female or Male patients between age 18-70

Must not have

Active neurologic disease, such as epilepsy

Current suicidal ideation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 weeks until the 8 weeks mark, every 4 weeks until 6 month mark and every two months until the 2 year mark

Summary

This trial aims to explore a surgical treatment for treatment refractory PTSD, a severe mental health condition that currently has limited effective treatment options. The study will involve three stages: pre-operative, operative, and

Who is the study for?

This trial is for individuals with severe PTSD that hasn't improved after trying other treatments. Participants must be eligible for surgery, willing to undergo various pre-operative tests like MRI and CT scans, and commit to regular follow-up visits post-surgery.

What is being tested?

The study is testing Deep Brain Stimulation (DBS) as a surgical treatment for refractory PTSD by targeting the subgenual cingulate. It includes three stages: pre-operative assessments, the surgical procedure of implanting electrodes and an internal pulse generator, followed by biweekly then monthly programming visits.

What are the potential side effects?

Potential side effects may include discomfort or complications from wearing a stereotactic frame during surgery, risks associated with general anesthesia, infection risk at incision sites, possible bleeding or brain injury during electrode insertion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PTSD according to the DSM-5.

Select...

I am between 18 and 70 years old.

Select...

My PTSD is severe, with a CAPS score of 50 or higher.

Exclusion Criteria

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

Select...

I have an active neurological condition like epilepsy.

Select...

I am currently experiencing thoughts of harming myself.

Select...

I have health issues that could make surgery risky.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 weeks until the 8 weeks mark, every 4 weeks until 6 month mark and every two months until the 2 year mark

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 weeks until the 8 weeks mark, every 4 weeks until 6 month mark and every two months until the 2 year mark

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 weeks until the 8 weeks mark, every 4 weeks until 6 month mark and every two months until the 2 year mark for reporting.