Novel Treatment of Emotional Dysfunction in Post Traumatic Stress Disorder (PTSD)

Summary

The objective will be to determine if adding repetitive transcranial magnetic stimulation prior to Cognitive Processing Therapy significantly enhances recovery from hyperarousal symptoms in individuals with combat related post traumatic stress disorder and improves clinical outcome.

The investigators have assembled a multimodal human performance laboratory including 64 channel EEG and repetitive transcranial magnetic stimulation system. These resources combined with the neuroimaging capabilities of the Advanced Imaging Research Center (AIRC) at UT Southwestern and skilled Cognitive Processing Therapy (CPT) practitioners will be used in this study.

The study involves approximately 19 visits. Treatment is once a week for 12 weeks followed by a 1 month, 3 month and 6 month follow-up appointments.

Conditions

• Post Traumatic Stress Disorder

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS)

For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.

BEHAVIORAL

Cognitive Processing Therapy

Cognitive Processing Therapy (CPT) is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.

DEVICE

Repetitive Transcranial Magnet Stimulation (rTMS)

For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46). The right frontal rTMS will safely, reversibly, and temporarily down modulate the right frontal lobe. The conducting coil is placed over the scalp while electrical current pulses pass through the coil. This alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds. The time-varying magnetic pulses induce an electrical field that will result in current flow in neural tissue, thereby activating or deactivating cortex subjacent to the coil.

Sponsors & Collaborators

• United States Department of Defense

  collaborator FED

• University of Texas Southwestern Medical Center

  collaborator OTHER

• The University of Texas at Dallas

  lead OTHER

Principal Investigators

• John Hart Jr., M.D. · University of Texas at Dallas

• F. Andrew Kozel, M.D. · University of Texas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-31

Primary Completion

2016-02-29

Completion

2016-02-29

FDA Device

Yes

Countries

• United States

Study Locations