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NCT03529981 · ClinicalTrials.gov registry record · NA

Wearable Emotion Prosthetics for Post Traumatic Stress Disorder

A NA study, sponsored by University of Pittsburgh.

Completed
Registry status
NA
Development phase
16
Enrollment target

NCT03529981 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 16 participants.

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The verdict

NCT03529981, a NA study, has completed, sponsored by University of Pittsburgh.

COMPLETED
Registry status
NA
Development phase
16 participants
Enrollment target

Study Summary

Involuntary stress reactions including hyper-reactivity and dissociation are key diagnostic features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention, Tuned Vibroacoustic Stimulation (TVS), capitalizing on a preserved neurocircuitry for sympathetic and parasympathetic system activity can be used to modify arousal responses, overriding otherwise prepotent negative stress reactions. PTSD has been characterized by dysregulated responses to stress as a result of severe acute or chronic trauma resulting in significantly impaired functioning, quality of life, and morbidity/mortality. Physiologically, PTSD severity has been associated with elevated sympathetic tone and low heart rate variability suggesting that parasympathetic tone is suppressed. Lower heart rate variability specifically, as a measure of parasympathetic tone, is closely associated with impaired performance and resilience. In our first study (in review), we showed that in some individuals, TVS is associated with increased heart rate variability and performance under stress along with reduced subjective stress. These results suggest that TVS could provide some therapeutic benefit in PTSD. N=100 individuals with mild-moderate PTSD (as assessed by PCL-5/CAP5), at least half of which are military Veterans, will be assessed physiologically during active interventions. Mechanisms of attentional focus on cognitive and emotional stimuli will be assessed. Participants will also have a real-world intervention to determine if TVS helps alleviate stress, symptoms, and medication burden in the real world when stress has been identified. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology.

Interventions

  • OTHER Tuned Vibroacoustic Stimulation (TVS)
  • OTHER no active intervention

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2018-04-09
Est. Completion 2021-12-18
Phase NA

Sponsor

University of Pittsburgh

1,238 total trials

What the Registry Record Tells You About NCT03529981

The ClinicalTrials.gov registry entry for NCT03529981 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Tuned Vibroacoustic Stimulation (TVS) is the first listed.

NCT03529981 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03529981 about?

NCT03529981 is a clinical study titled "Wearable Emotion Prosthetics for Post Traumatic Stress Disorder". Involuntary stress reactions including hyper-reactivity and dissociation are key diagnostic features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention, Tuned V...

What is the current status of trial NCT03529981?

This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2018-04-09. Estimated completion is 2021-12-18.

What interventions are being tested in trial NCT03529981?

The interventions under investigation include: Tuned Vibroacoustic Stimulation (TVS) (OTHER), no active intervention (OTHER).

Who is sponsoring clinical trial NCT03529981?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.