Targeted Plasticity Therapy for PTSD

Part of paid clinical trials in Austin, Texas.

Sponsor
The University of Texas at Dallas
Study ID
NCT06266364
Status
Recruiting
Apply to this trial

Conditions

  • PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
22 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • Active VNS stimulation — DEVICE
    The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
  • Sham VNS stimulation — DEVICE
    The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1

Study Details

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)

Key Dates

Start date
Dec 30, 2024
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Immediate VNS Group
    The participants in this arm will be implanted with the device and will receive active VNS stimulations in phase 1 as well as phase 2 of the study.
  • Sham Comparator: Delayed VNS Group
    The participants in this arm will be implanted with the device but will receive sham VNS stimulations in phase 1 of the study and active VNS in phase 2 of the study.

Primary Outcome Measure

ReStore System Safety [ Time Frame: From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
The University of Texas Health Austin Ambulatory Surgery CenterAustinTexas78712-
Baylor University Medical CenterDallasTexas75246
(214) 865-2416
Texas Biomedical Device CenterRichardsonTexas75080
Amy Porter
972-883-7256

Find similar trials in Austin, TX

By research site
The University of Texas Health Austin Ambulatory Surgery Center· Austin, TXBaylor University Medical Center· Dallas, TXTexas Biomedical Device Center· Richardson, TX

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