TDCS-Augmented Prolonged Exposure Therapy

Summary

The purpose of this study is to determine the effects of a brain stimulation technique known as transcranial direct current stimulation, or tDCS, on the benefits of Prolonged Exposure therapy, or PE, which is an effective treatment for posttraumatic stress disorder, or PTSD. tDCS has been demonstrated to be safe and effective for influencing brain activity by passing a weak electrical current through the scalp. In this study, tDCS is provided in addition to PE treatment, through the National Crime Victim's Research and Treatment Center at MUSC, or the PTSD Clinical Team Clinic within the Ralph H. Johnson VA Medical Center.

Conditions

• Posttraumatic Stress Disorder
• PTSD
• Anxiety
• Depression

Interventions

DEVICE

Transcranial Direct Current Stimulation (tDCS)

Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.

BEHAVIORAL

Prolonged Exposure Therapy

All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.

Sponsors & Collaborators

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Adam R. Cobb, Ph.D. · Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

• Lisa M. McTeague, Ph.D. · Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

• Bethany C. Wangelin, Ph.D. · Medical University of South Carolina & Ralph H. Johnson VAMC Consortium

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-01

Primary Completion

2022-05-01

Completion

2022-05-01

FDA Device

Yes

Countries

• United States

Study Locations