Deep Brain Stimulation for Patients with Severe PTSD

Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-Traumatic Stress Disorder (PTSD)

This study is testing if a surgery that uses deep brain stimulation can help people with severe PTSD who haven't found relief from other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06705296 on ClinicalTrials.gov

What this trial studies

This clinical trial explores the use of deep brain stimulation (DBS) as a surgical treatment for patients suffering from treatment refractory post-traumatic stress disorder (PTSD). The study involves three stages: pre-operative assessments including neuroimaging and psychological testing, the surgical implantation of a DBS device targeting the subgenual cingulate, and post-operative evaluations. This is a phase I, non-randomized pilot trial aimed at assessing the safety and efficacy of DBS in alleviating severe PTSD symptoms. The trial seeks to provide a novel intervention for patients who have not responded to conventional therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of treatment-resistant PTSD and severe symptoms.

Not a fit: Patients with active psychosis, neurological diseases, or substance dependence may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce PTSD symptoms in patients who have not benefited from existing therapies.

How similar studies have performed: While this approach is novel for PTSD, deep brain stimulation has shown success in treating other psychiatric disorders, such as depression.

Eligibility criteria

Inclusion Criteria:

1. Female or Male patients between age 18-70
2. Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
3. Treatment Resistance as defined by the persistence of clinical symptoms despite adequate treatment with four modalities, including a) selective serotonin reuptake inhibitors, b) cognitive behavioral therapy, c) other classes of medications and/or psychotherapy.
4. Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores≥ 50.
5. A pattern of chronic stable PTSD lasting at least 1 year.
6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols.

Exclusion Criteria:

1. Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
2. Active neurologic disease, such as epilepsy
3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine.
4. Current suicidal ideation
5. Any contraindication to MRI or PET scanning
6. Likely to relocate or move out of the country during the study's duration.
7. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
8. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Where this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Nir Lipsman, MD PhD — Sunnybrook Health Sciences Centre
• Study coordinator: Anusha Baskaran, PhD

Conditions PTSD; DBS; Post Traumatic Stress Disorder