Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06705296
PHASE1

Deep Brain Stimulation for Refractory PTSD

Sponsor: Sunnybrook Health Sciences Centre

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-11-01

Completion Date

2026-11-01

Last Updated

2024-11-26

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Open Label Deep Brain Stimulation

Patients will receive open label deep brain stimulation

DEVICE

Double blinded Deep Brain Stimulation

Patients will receive double blinded deep brain stimulation

BEHAVIORAL

Prolonged exposure therapy

Patients will receive prolonged exposure therapy

DEVICE

Closed loop Deep brain stimulation

Patients will receive closed loop deep brain stimulation

Locations (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada