Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-Traumatic Stress Disorder (PTSD): Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post-Traumatic Stress Disorder
- Sponsor
- Sunnybrook Health Sciences Centre
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events using SAFTEE collateral effects scale.
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a phase I, non-blinded, non-randomized, pilot trial for safety and efficacy of deep brain stimulation for PTSD. A substantial number of individuals continue to experience PTSD symptoms despite appropriate medical treatment. In psychotherapy-based studies, over 30% of patients that completed a full course of treatment continue to meet criteria for PTSD. Response rates to treatment with SSRIs are usually no higher than 60%. This study would be the first exploration of a surgical therapy for refractory PTSD. The subgenual cingulate plays a role in mechanisms of this disorders and has been successfully targeted with DBS for the treatment of depression. The development of a therapy that targets brain structures known to play a role in this disease would be a substantial step forward in the treatment and understanding of these conditions.
Investigators
Dr. Nir Lipsman
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
Inclusion Criteria
- •Female or Male patients between age 18-70
- •Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM V).
- •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.
- •Severe forms of the disease as measured by Clinician Administered PTSD scale (CAPS) scores ≥
- •A pattern of chronic stable PTSD lasting at least 1 year.
- •Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria
- •Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
- •Active neurologic disease, such as epilepsy
- •Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
- •Current suicidal ideation
- •Any contraindication to MRI or PET scanning
- •Likely to relocate or move out of the country during the study's one year duration
- •Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
- •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
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events using SAFTEE collateral effects scale.
Time Frame: 1 year
Adverse events (AE) will be recorded and categorized according to severity and relationship to procedure. All AEs will be assessed for their relationship to the study procedure.
Secondary Outcomes
- Davidson Trauma Scale (DTS)(1 year)
- Clinical Global Impression (CGI)(1 year)
- Hamilton Depression Rating Scale (HAMD)(1 year)
- Beck's Anxiety Inventory (BAI)(1 year)
- Global Functioning Assessment (GFA)(1 year)
- Hamilton Anxiety Rating Scale (HAMA)(1 year)
- Short PTSD Rating Interview (SPRINT)(1 year)
- 36-Item Short Form Health Survey (SF-36)(1 year)
- Beck's Depression Inventory (BDI)(1 year)
- Positive and negative affect (PANAS)(1 year)
- Clinician-Administered PTSD Scale (CAPS)(1 year)
- The State-Trait Anxiety Inventory (STAI)(1 year)
- Sheehan disability scale (SDS)(1 year)