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NCT04064762 · ClinicalTrials.gov registry record · NA
Targeted Plasticity Therapy for Posttraumatic Stress Disorder
A NA study of Post Traumatic Stress Disorder, sponsored by Baylor Research Institute.
- Active
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT04064762: Active NA study of Post Traumatic Stress Disorder, sponsored by Baylor Research Institute.
NCT04064762 is a NA study of Post Traumatic Stress Disorder that is active but no longer recruiting, run by Baylor Research Institute. The registered enrollment target is 9 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04064762, a NA study of Post Traumatic Stress Disorder, is active but no longer recruiting, sponsored by Baylor Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Paired Vagus Nerve Stimulation
Study Locations (1)
Texas
- Baylor University Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2024-04 |
| Phase | NA |
What the registry record for NCT04064762 still lists
NCT04064762 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 1 intervention - of which Paired Vagus Nerve Stimulation is the first listed.
NCT04064762 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04064762 about?
NCT04064762 is a clinical study titled "Targeted Plasticity Therapy for Posttraumatic Stress Disorder". 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 nove...
What is the current status of trial NCT04064762?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 9 participants. The study started on 2020-12-16. Estimated completion is 2024-04.
What conditions does trial NCT04064762 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT04064762?
The interventions under investigation include: Paired Vagus Nerve Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04064762?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04064762 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04064762's enrollment target sits among peer trials
9 251st of 262 higher than 8 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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