Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06266364
NA

Targeted Plasticity Therapy for PTSD

Sponsor: The University of Texas at Dallas

View on ClinicalTrials.gov

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)

Official title: Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder

Key Details

Gender

All

Age Range

22 Years - 79 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-12-30

Completion Date

2028-06

Last Updated

2025-07-03

Healthy Volunteers

No

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

Locations (3)

The University of Texas Health Austin Ambulatory Surgery Center

Austin, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

Texas Biomedical Device Center

Richardson, Texas, United States