Deep Brain Stimulation for Refractory PTSD

Recruiting now · Phase 1

Conditions studied: PTSD

In brief

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.

Key facts

Study ID: NCT06705296
Run by: Sunnybrook Health Sciences Centre
People needed: 20
Starts: 2024-11-01
Expected to finish: 2026-11-01
Last updated by the study team: 2024-11-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Female or Male patients between age 18-70
Diagnosis of posttraumatic stress disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5).
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.

You may not qualify if…

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 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.

Where it is running

Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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