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Wearable Emotion Prosthetics for Post Traumatic Stress Disorder (EP-PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529981
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Greg Siegle, University of Pittsburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Health Behavior Other: Tuned Vibroacoustic Stimulation (TVS) Other: no active intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: randomized, controlled factorial within subject design
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : December 18, 2022
Estimated Study Completion Date : December 18, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Stress incidents without TVS
a fraction of physiological detected stress incidents will not trigger TVS
Other: no active intervention
No intervention will be administered

Experimental: TVS in response to participant initiation or stress detection
The majority of detected stress incidents will trigger TVS. Participants can also trigger TVS voluntarily
Other: Tuned Vibroacoustic Stimulation (TVS)
TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance




Primary Outcome Measures :
  1. Change in symptom ratings from pre- to post- [ Time Frame: Change in symptom ratings over the approximately two weeks of the acute intervention (pre- to post- assessment) ]
    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.

  2. Change in resting Heart Rate Variability (HRV) from pre- to post- [ Time Frame: HRV will be measured during the entire study which is two weeks ]
    HRV, an index of parasympathetic reactivity, will be obtained throughout the day during the study. Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation. Spline fitting will be used to create a smoothed estimate of trajectory, the beginning and end points of which will be compared.


Secondary Outcome Measures :
  1. Change in Heart Rate Variability (HRV) during information processing tasks (composite) [ Time Frame: HRV will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits. ]
    HRV, an index of parasympathetic reactivity, will be obtained during laboratory information processing tasks (paced auditory serial attention, emotional picture viewing). Increased HRV indicates increased parasympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.

  2. Galvanic skin response (GSR) during information processing tasks (composite) [ Time Frame: GSR will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits. ]
    GSR, index of sympathetic reactivity, will be obtained during lab tasks before and after the intervention. Decreased GSR indicates decreased sympathetic reactivity, which suggests an increased physiological indicator of emotion regulation.

  3. prefrontal gamma band EEG during information processing tasks (composite) [ Time Frame: EEG will be measured during the approximately 1 hour of information processing tasks, which will be administered approximately 2 weeks apart, at the pre- and post- intervention assessment visits. ]
    prefrontal gamma band EEG will be obtained during lab information processing tasks. Increased prefrontal gamma band EEG suggests an increased physiological indicator of emotion regulation.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male/female who are 18 - 58 years of age
  • For PTSD participants, must meet current DSM-V criteria for PTSD based on the PCL-5 (Score > 33) and MINI PTSD Scale (administered in lab).
  • If taking psychoactive medications, must be on a stable regimen for 3 weeks or more.
  • Must have a functioning smartphone with Apple iOS or Android

Exclusion Criteria:

  • Refusal or inability to provide informed consent
  • Current suicidal or homicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment.
  • Current or recent (within the last 8 weeks) physically aggressive behavior.
  • Meets current DSM-V criteria for substance dependence ((serious substance use in DSM-V parlance, not in remission) except nicotine and caffeine), traumatic brain injury, bipolar affective disorder, schizophrenia or any psychotic disorder.
  • Has unstable or serious medical illness, including history of stroke, epileptic disorder, or unstable cardiac disease, that would interfere with participation in treatment.
  • Taking medications that could affect thinking which must be taken on the day of testing, or dependence on psychoactive drugs (prescription or non-prescription) that could affect thinking. That is, participants need to be able to think clearly to complete the proposed information processing tasks. And they need to be able to learn to be able to make use of the intervention. Examples of drugs which could affect performance on cognitive tasks or the administered physiological measures include beta-blockers, benzodiazepines, antipsychotics, stimulants (except for treatment of ADD/ADHD), narcotics, and anti--Parkinsonian drugs.
  • Severe cognitive impairment or severe trauma
  • Unable to comprehend or communicate in English, and unable to complete questionnaires written in English.
  • Having any eye problems or difficulties in corrected vision or hearing, including poor color vision
  • Having a North American Adult Reading Test (NAART) equivalent FSIQ < 85
  • Severe or poorly controlled concurrent medical disorders or require medication that could cause negative thinking

Specific Exclusions for acoustic vibration include:

-- Any electrical implant (pacemaker, vagus nerve stimulator, etc).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529981


Contacts
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Contact: Lisa Stupar 412-980-5342 StuparLM@upmc.edu

Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lisa Stupar    412-980-5342    StuparLM@upmc.edu   
Contact: Marlee Pyzewski    412-8643515    pyzewskiml@upmc.edu   
Principal Investigator: Greg Siegle, PhD         
Sub-Investigator: Shan Gao, MD, PhD         
Sub-Investigator: David Rabin, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Greg Siegle, MD Western Psychiatric Institute and Clinic
  Study Documents (Full-Text)

Documents provided by Greg Siegle, University of Pittsburgh:
Informed Consent Form  [PDF] April 2, 2018
Study Protocol  [PDF] May 7, 2018
Statistical Analysis Plan  [PDF] May 7, 2018

Publications of Results:
Other Publications:

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Responsible Party: Greg Siegle, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03529981    
Other Study ID Numbers: PRO17110107
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Following publication of primary results, individual anonymized data on primary outcome measures will be made available to other researchers. Before publication, primary outcome measures will be shared in negotiation with a proposed analysis plan from qualified investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Following publication - available to all. Before publication - upon negotiation with qualified investigators
Access Criteria: Before publication - available in negotiation with Greg Siegle (gsiegle@pitt.edu). After publication the location of a data repository will be listed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Greg Siegle, University of Pittsburgh:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders