Deep Brain Stimulation for Refractory PTSD

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.

Conditions

• PTSD

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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre

  lead OTHER

Principal Investigators

• Nir Lipsman, MD PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2026-11-01

Completion

2026-11-01

Countries

• Canada

Study Locations