Targeted Plasticity Therapy for Posttraumatic Stress Disorder

Summary

Posttraumatic stress disorder is a debilitating condition that develops in the aftermath of a traumatic experience, leading to hyperarousal, heightened anxiety, and uncontrolled fear that can be driven by intrusive memories or trauma reminders. The Texas Biomedical Device Center has developed a novel technique, termed targeted plasticity therapy (TPT), to boost neuroplasticity in conjunction with various forms of rehabilitation, including prolonged exposure therapy. The technique involves stimulation of the vagus nerve. The purpose of this open-label pilot study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with PTSD when paired with prolonged exposure therapy. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial.

Conditions

• Post Traumatic Stress Disorder

Interventions

DEVICE

Paired Vagus Nerve Stimulation

Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.

Sponsors & Collaborators

• Defense Advanced Research Projects Agency

  collaborator FED

• The University of Texas at Dallas

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Baylor Research Institute

  lead OTHER

Principal Investigators

• Michael Kilgard, PhD · University of Texas at Dallas

• Robert Rennaker, PhD · University of Texas at Dallas

• Seth Hays, PhD · University of Texas at Dallas

• Jane Wigginton, MD · University of Texas Southwestern Medical Center

• Michael Foreman, MD FACS · Baylor Health Care System

• Mark Powers, PhD · Baylor Health Care System

• Richard Naftalis, MD, FAANS, FACS · Baylor Health Care System

• Ann Marie Warren, PhD · Baylor Health Care System

• Jasper Smits, PhD · The University of Texas at Austin

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-16

Primary Completion

2023-02-28

Completion

2024-04-30

FDA Device

Yes

Countries

• United States

Study Locations