A Pilot Study of Deep Brain Stimulation of the Amygdala for Treatment-Refractory Combat Post-Traumatic Stress Disorder

Summary

The purpose of this study is to determine whether deep brain stimulation of the basolateral nucleus (BLn) of the amygdala, on both sides of the brain, can safely reduce symptoms of post-traumatic stress disorder (PTSD) in combat veterans whose condition has not improved despite extensive treatment with currently available medication and psychotherapy interventions.

Conditions

• Post Traumatic Stress Disorder

Interventions

DEVICE

Week 0 Medtronic 3387 electrodes/Activa PC amygdala DBS

Subjects undergo the placement of a Leksell (Elekta, Atlanta, GE) stereotactic frame. Electrode trajectory planned using stereotactic software (BrainLab, Germany). Traditional trans-frontal trajectory used to implant Medtronic #3387 DBS electrodes bilaterally in the BLn. A curvilinear incision will be made 3 cm lateral to midline and 1 cm in front of the coronal suture. A burr hole will be placed with a high-speed drill for placement of a Stimloc device to hold the electrode in place. The dura will be opened, coagulated back and the cortex exposed, coagulated, and pierced. The electrode will be introduced using a cannula. Each electrode contact will be stimulated up to 7 V to confirm the absence of immediate side effects; first left, then right. Electrode wires will be tunneled under skin to upper chest and connected to Medtronic Activa PC dual channel pulse generator. Both groups keep stimulators off until week 0, then this group has stimulators turned on.

DEVICE

Week 12 Medtronic 3387 electrodes/Activa PC amygdala DBS

Subjects undergo the placement of a Leksell (Elekta, Atlanta, GE) stereotactic frame. Electrode trajectory planned using stereotactic software (BrainLab, Germany). Traditional trans-frontal trajectory used to implant Medtronic #3387 DBS electrodes bilaterally in the BLn. A curvilinear incision will be made 3 cm lateral to midline and 1 cm in front of the coronal suture. A burr hole will be placed with a high-speed drill for placement of a Stimloc device to hold the electrode in place. The dura will be opened, coagulated back and the cortex exposed, coagulated, and pierced. The electrode will be introduced using a cannula. Each electrode contact will be stimulated up to 7 V to confirm the absence of immediate side effects; first left, then right. Electrode wires will be tunneled under skin to upper chest and connected to Medtronic Activa PC dual channel pulse generator. Both groups keep stimulators off until week 0. This group has stimulators turned on at week 12.

Sponsors & Collaborators

• VA Greater Los Angeles Healthcare System

  collaborator FED

• US Department of Veterans Affairs

  lead FED

Principal Investigators

• Ralph J Koek, MD · VA Greater Los Angeles

• Jean-Philippe Langevin, MD · Southern Arizona VA Healthcare System AND VA Greater Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• United States

Study Locations