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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: Completed NA study, sponsored by University of Pittsburgh.
NCT03529981 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Subjective affect / symptom ratings will be obtained daily. Spline fitting will be used to create a smoothed estimate of trajectory, the beginning and end points of which will be compared.
Interventions
- OTHER Tuned Vibroacoustic Stimulation (TVS)
- OTHER no active intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2021-12-18 |
| Phase | NA |
What the finished NCT03529981 record still lists
NCT03529981 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Tuned Vibroacoustic Stimulation (TVS) is the first listed.
NCT03529981 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03529981's enrollment target sits among peer trials
16 1871st of 2000 higher than 120 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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