NCT03529981: EP-PTSD

Wearable Emotion Prosthetics for Post Traumatic Stress Disorder

Completed NA Last updated 28 January 2022

What this trial tests

NA trial testing Tuned Vibroacoustic Stimulation (TVS) in Health Behavior in 16 participants. Completed in 18 December 2021.

Timeline

9 April 2018

Primary endpoint
18 December 2021

18 December 2021

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	basic science
Enrollment	16
Start date	9 April 2018
Primary completion	18 December 2021
Estimated completion	18 December 2021
Sites	1 location across United States

Drugs / interventions tested

• Tuned Vibroacoustic Stimulation (TVS)
• no active intervention

Conditions studied

• Health Behavior — all drugs for Health Behavior →

Sponsor

University of Pittsburgh

Who can join

Adults 18 to 58, any sex, with Health Behavior. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.