RecruitingPhase 1NCT06705296

Deep Brain Stimulation for Refractory PTSD

Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-Traumatic Stress Disorder (PTSD)


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

20 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether deep brain stimulation (DBS) — a surgical procedure that implants a device to send electrical signals to specific brain regions — can reduce severe, treatment-resistant PTSD symptoms. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed PTSD diagnosis - Your PTSD has not improved despite trying at least four types of treatment, including antidepressants, cognitive behavioral therapy, other medications, and other psychotherapy approaches - Your PTSD is severe (CAPS score of 50 or higher) and has been stable and chronic for at least one year - You are able to consent and attend all required appointments **You may NOT be eligible if...** - You have a history of psychosis or other serious psychiatric conditions - You have other conditions that would make brain surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOpen Label Deep Brain Stimulation

Patients will receive open label deep brain stimulation

DEVICEDouble blinded Deep Brain Stimulation

Patients will receive double blinded deep brain stimulation

BEHAVIORALProlonged exposure therapy

Patients will receive prolonged exposure therapy

DEVICEClosed loop Deep brain stimulation

Patients will receive closed loop deep brain stimulation


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT06705296


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