Status:
UNKNOWN
Deep Brain Stimulation for Treatment Refractory PTSD
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Post-Traumatic Stress Disorder
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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 ≥ 50.
- 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
- 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
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03416894
Start Date
January 19 2018
End Date
November 10 2024
Last Update
December 5 2023
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5