NCT06705296 Deep Brain Stimulation for Refractory PTSD
| NCT ID | NCT06705296 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sunnybrook Health Sciences Centre |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-11-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 the operative stage, patient will have a stereotactic frame attached directly to their skull. The patient will then undergo a computed tomography (CT) scan with the frame in place, followed by transport directly to the operating room. A skin incision will be made and two burr holes drilled through the skull. After target identification DBS electrodes will be inserted and fixed in place. Patients will be then immediately anesthetized (general anesthesia) for the next step of the surgery. This will involve implanting an internal pulse generator (IPG) under the collarbone and connecting it to the DBS electrodes. During the post-operative phase, patients will return to the clinic 2 weeks after surgery.DBS programming visits will happen biweekly for three months, and monthly thereafter.
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.
Contact & Investigator
Nir Lipsman, MD PhD
PRINCIPAL INVESTIGATOR
Sunnybrook Health Sciences Centre
Frequently Asked Questions
Who can join the NCT06705296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06705296 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06705296 currently recruiting?
Yes, NCT06705296 is actively recruiting participants. Contact the research team at anusha.baskaran@sunnybrook.ca for enrollment information.
Where is the NCT06705296 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06705296 clinical trial?
NCT06705296 is sponsored by Sunnybrook Health Sciences Centre. The principal investigator is Nir Lipsman, MD PhD at Sunnybrook Health Sciences Centre. The trial plans to enroll 20 participants.
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