CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Tuned Vibroacoustic Stimulation (TVS) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03529981
NCT03529981N/ACompleted

Wearable Emotion Prosthetics for Post Traumatic Stress Disorder

University of Pittsburgh·interventional·Posted May 21, 2018·Updated Jan 28, 2022

In Brief

A clinical study evaluating Tuned Vibroacoustic Stimulation (TVS) and no active intervention for Health Behavior. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealth Behavior
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMay 21, 2018
Enrollment StartApr 9, 2018
Primary CompletionDec 18, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.1 years ago

Interventions

Tuned Vibroacoustic Stimulation (TVS)other

TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance

no active interventionother

No intervention will be administered