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Deep Brain Stimulation for Refractory PTSD

RecruitingPhase 1Ages 18 Years - 70 YearsAllSunnybrook Health Sciences Centre
NCT06705296 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Treatment refractory PTSD is a chronic and debilitating psychiatric disorder associated with high morbidity. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress has been made in altering the natural history of the condition or its outcome. This study would be the first exploration of a surgical therapy for refractory PTSD. The subgenual cingulate plays a role in mechanisms of this disorder and has been successfully targeted with DBS for the treatment of depression The study will proceed in three stages: pre-operative, operative and post-operative. In the pre-operative stage, consent will be obtained and patients will be scheduled for additional investigations, including neuroimaging (MRI), neuropsychological testing, psychophysiological testing, and a pre-operative assessment by the anesthesia service. In th

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📋 Eligibility rules (as published)
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.
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What it tests

  • Open Label Deep Brain Stimulation
  • Double blinded Deep Brain Stimulation
  • Prolonged exposure therapy
  • Closed loop Deep brain stimulation
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Where

1 site
Sunnybrook Health Sciences Centre
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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