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Clinical Trials/NCT04064762
NCT04064762
Active, Not Recruiting
N/A

Targeted Plasticity Therapy for Posttraumatic Stress Disorder

Baylor Research Institute1 site in 1 country9 target enrollmentDecember 16, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder
Sponsor
Baylor Research Institute
Enrollment
9
Locations
1
Primary Endpoint
Incidence of Adverse Events [Device Safety]
Status
Active, Not Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 16, 2020
End Date
April 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of Adverse Events [Device Safety]

Time Frame: From Week 1 through study follow-up, approximately two years from the date of implant

Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis.

Secondary Outcomes

  • PTSD Checklist for DSM-5 (PCL-5)(Weeks 1, 9-15, 19, 36, 62)
  • Generalized Anxiety Disorder 7-item Scale (GAD-7)(Weeks 9, 15, 19, 36, 62)
  • Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)(Weeks 1, 9, 15, 19, 36, 62)
  • Patient Health Questionnaire-9 (PHQ-9)(Weeks 1, 9-15, 19, 36, 62)
  • Posttraumatic Cognitions Inventory (PTCI)(Weeks 9-15, 19, 36, 62)

Study Sites (1)

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