RecruitingNot ApplicableNCT06266364

Targeted Plasticity Therapy for PTSD

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

Sponsor

The University of Texas at Dallas

Enrollment

20 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

PTSD - Post Traumatic Stress Disorder

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)

Eligibility

Min Age: 22 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called Targeted Plasticity Therapy (TPT) for PTSD — it combines vagus nerve stimulation (a device surgically implanted in the chest that sends mild electrical pulses to the brain through a nerve in the neck) with standard trauma-focused therapy sessions. **You may be eligible if...** - You are between 22 and 79 years old - You have had chronic PTSD for at least 3 months - Your PTSD symptoms are still significantly affecting your life (PCL-5 score above 33) - You have already tried at least one standard PTSD treatment that did not work - You are a suitable candidate for a minor surgical device implant **You may NOT be eligible if...** - You are currently doing prolonged exposure therapy elsewhere - You have had a prior injury to the vagus nerve - You have previously used vagus nerve stimulation - You have psychiatric conditions or cognitive problems that would interfere with treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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