Deep Brain Stimulation for Refractory PTSD

Launched by SUNNYBROOK HEALTH SCIENCES CENTRE · Nov 21, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical treatment for people with severe post-traumatic stress disorder (PTSD) that has not improved with standard therapies. The researchers are specifically looking at a procedure called deep brain stimulation (DBS), which has shown promise in treating depression by targeting a specific brain area known to be involved in PTSD. This study aims to see if DBS can help reduce PTSD symptoms in patients who haven't found relief from traditional treatments like medication or therapy.

To participate, patients need to be between 18 and 70 years old and have a diagnosis of PTSD that has not responded to at least four different treatment options, including medications and therapy. They will go through several stages in the study: before surgery, during the operation, and after the procedure. This includes tests to assess their condition and a surgical procedure where electrodes are placed in their brain. After surgery, there will be follow-up visits to adjust the treatment and monitor progress. It's important to note that certain individuals, such as those with active substance abuse issues or certain neurological conditions, may not be eligible for this trial.

Gender

ALL

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.