NCT04064762

Targeted Plasticity Therapy for Posttraumatic Stress Disorder

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Paired Vagus Nerve Stimulation	Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.

Timeline

• Start date: 2020-12-16
• Primary completion: 2023-02-01
• Completion: 2024-04-01
• First posted: 2019-08-22
• Last updated: 2023-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study