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Targeted Plasticity Therapy for PTSD

NCT06266364 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-03

No results posted yet for this study

Summary

Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)

Conditions

  • PTSD, Post Traumatic Stress Disorder

Interventions

DEVICE

Active VNS stimulation

The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1

DEVICE

Sham VNS stimulation

The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • The University of Texas at Dallas

    lead OTHER

Principal Investigators

  • Jane Wigginton, MD · The University of Texas at Dallas

  • Robert Rennaker, PhD · The University of Texas at Dallas

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

  • Mark Powers, PhD · Baylor Scott & White

  • Michael Kilgard, PhD · The University of Texas at Dallas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2027-09-30
Completion
2028-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266364 on ClinicalTrials.gov