Wearable Emotion Prosthetics for Post Traumatic Stress Disorder
NCT ID: NCT03529981
Last Updated: 2022-01-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
16 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-04-09
Study Completion Date
2021-12-18
Brief Summary
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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.
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.
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Detailed Description
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This protocol will examine and elucidate a mechanistic model for tuned vibroacoustic stimulation (TVS), an exteroceptive cue that has been shown to reduce subjective and physiological indicators of stress and increase behavioral performance in healthy subjects. In this study, we will test whether TVS can reduce subjective and physiological signs of stress, improve performance, alleviate symptoms, and reduce medication burden in adults with post-traumatic stress disorder (PTSD). This protocol will also examine whether software that cues TVS in response to biological stress markers helps users detect, regulate, and develop long-term resilience to stress outside of the laboratory.
Aim 1: Examine how TVS alters calmness and stress markers. Our overall hypothesis is that TVS, in combination with some other task, increases performance on that task by decreasing stress and increasing emotion regulation.
Hypothesis 1: TVS during an attention task will lead to decreased GSR, increased HRV, and increases in prefrontal gamma and theta band EEG, along with improved behavioral performance on a focused attention, working memory and emotional information processing task. TVS will also reduce subjective stress levels.
Aim 2: Examine the extent to which software, which monitors real time biological stress markers of users, and in response, automatically signals wearable hardware to deliver TVS when user is stressed, will be able to help users detect, regulate, and develop long-term resilience to stress outside the laboratory for two weeks.
Hypothesis 2.1: Evaluate whether subjects with PTSD in the real world will use our software to detect and alert them of stress dynamically and if this is associated with stress regulation.
Hypothesis 2.2: Examine whether TVS is associated with stress regulation. Hypothesis 2.3: Examine whether TVS is associated with reduction in PTSD symptoms and, possibly, medication burden.
Over 39 million Americans suffer from excessive chronic stress, which can be psychologically and physically debilitating (Salleh, 2008). Untreated chronic stress plays a role in the development of major illnesses such as cardiovascular disease, obesity, anxiety and depression (Dallman et al., 2006; Swaab, Bao, \& Lucassen, 2005). Post-traumatic stress disorder (PTSD), is a severe mental illness that impacts millions of veterans and civilians nationwide. Existing treatments for chronic stress and PTSD are often ineffective, have adverse effects, and are prohibited by cost, time-commitment, and accessibility, resulting in high rates of substance abuse and suicide (Jonas et al., 2013; Watts et al., 2013). Stress in general, and PTSD more specifically, are characterized by hyper-reactivity in the sympathetic nervous system which is associated with increased arousal and vigilance, and compromised reactivity of the parasympathetic nervous system, which helps to regulate emotion and stress responses (Kibler, Tursich, Ma, Malcolm, \& Greenbarg, 2014; Lehrer \& Gevirtz, 2014).
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. HRV is widely used as a biomarker for the coordinated activity of the sympathetic and parasympathetic nervous symptom. A calmer, less stressful state is typically marked by increased HRV, likely attributed to respiration based parasympathetic stimulation (Grossman \& Taylor, 2007). GSR is also a reliable index for sweat gland activity and changes in activation level of the sympathetic nervous system, and GSR usually increases with higher levels of stress (Mohan, Sharma, \& Bijlani, 2011). EEG changes, such as elevated prefrontal gamma and theta, have also been associated with state of relaxed alertness. Our initial data (submitted) suggest that for some individuals, TVS can boost heart rate variability and performance under stress while reducing subjective stress. These results suggest that TVS could provide some therapeutic benefit in PTSD.
Large scientific literature supports the role of vibration in regulating stress physiology (Takahashi, Ohashi, \& Yokoyama, 2011; M. Uchikune, 2002; M. Uchikune, 2004). For example, slow whole-body vibration, in the 0.01 to 0.3 Hz range, is associated with increased ratings of pleasantness and increased parasympathetic tone (M. Uchikune, 2002; M. Uchikune, 2004). Stimulation at about 100 Hz has been shown to activate the posterior insula (Coghill et al., 1994) which is associated with increased attention to interoception, as promoted in many meditative traditions. Transcutaneous targets for the vibration frequencies have also been identified, including stellate ganglion and vagus nerve (Cipriano et al., 2014; Fang et al., 2016).
In this study, we will be testing the potential for TVS to increase well-being (subjective calmness, increased performance, and physiological reactivity) in the PTSD population. Positive results would suggest that reduction in symptomatology may be possible without effort, and in lieu of specific interventions with medications or psychotherapy. A wearable form of TVS technology will be examined in a real-world setting. We will use ambulatory assessment to detect physiological indications of stress unique to each user and to provide user-optimized TVS, examining whether it increases parasympathetic nervous system reactivity in response to stress, thus decreasing subjective stress just as a user's stress begins to increase.
Aim 1: Examine how TVS alters calmness and stress markers. Our overall hypothesis is that TVS, in combination with some other task, increases performance on that task by decreasing stress and increasing emotion regulation.
Hypothesis 1: TVS during an attention task will lead to decreased GSR, increased HRV, and increases in prefrontal gamma and theta band EEG, along with improved behavioral performance on a focused attention, working memory and emotional information processing task. TVS will also reduce subjective stress levels.
Aim 2: Examine the extent to which software, which monitors real time biological stress markers of users, and in response, automatically signals wearable hardware to deliver TVS when user is stressed, will be able to help users detect, regulate, and develop long-term resilience to stress outside the laboratory for two weeks.
Hypothesis 2.1: Evaluate whether subjects with PTSD in the real world will use our software to detect and alert them of stress dynamically and if this is associated with stress regulation.
Hypothesis 2.2: Examine whether TVS is associated with stress regulation. Hypothesis 2.3: Examine whether TVS is associated with reduction in PTSD symptoms and, possibly, medication burden.
Over 39 million Americans suffer from excessive chronic stress, which can be psychologically and physically debilitating (Salleh, 2008). Untreated chronic stress plays a role in the development of major illnesses such as cardiovascular disease, obesity, anxiety and depression (Dallman et al., 2006; Swaab, Bao, \& Lucassen, 2005). Post-traumatic stress disorder (PTSD), is a severe mental illness that impacts millions of veterans and civilians nationwide. Existing treatments for chronic stress and PTSD are often ineffective, have adverse effects, and are prohibited by cost, time-commitment, and accessibility, resulting in high rates of substance abuse and suicide (Jonas et al., 2013; Watts et al., 2013). Stress in general, and PTSD more specifically, are characterized by hyper-reactivity in the sympathetic nervous system which is associated with increased arousal and vigilance, and compromised reactivity of the parasympathetic nervous system, which helps to regulate emotion and stress responses (Kibler, Tursich, Ma, Malcolm, \& Greenbarg, 2014; Lehrer \& Gevirtz, 2014).
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. HRV is widely used as a biomarker for the coordinated activity of the sympathetic and parasympathetic nervous symptom. A calmer, less stressful state is typically marked by increased HRV, likely attributed to respiration based parasympathetic stimulation (Grossman \& Taylor, 2007). GSR is also a reliable index for sweat gland activity and changes in activation level of the sympathetic nervous system, and GSR usually increases with higher levels of stress (Mohan, Sharma, \& Bijlani, 2011). EEG changes, such as elevated prefrontal gamma and theta, have also been associated with state of relaxed alertness. Our initial data (submitted) suggest that for some individuals, TVS can boost heart rate variability and performance under stress while reducing subjective stress. These results suggest that TVS could provide some therapeutic benefit in PTSD.
Large scientific literature supports the role of vibration in regulating stress physiology (Takahashi, Ohashi, \& Yokoyama, 2011; M. Uchikune, 2002; M. Uchikune, 2004). For example, slow whole-body vibration, in the 0.01 to 0.3 Hz range, is associated with increased ratings of pleasantness and increased parasympathetic tone (M. Uchikune, 2002; M. Uchikune, 2004). Stimulation at about 100 Hz has been shown to activate the posterior insula (Coghill et al., 1994) which is associated with increased attention to interoception, as promoted in many meditative traditions. Transcutaneous targets for the vibration frequencies have also been identified, including stellate ganglion and vagus nerve (Cipriano et al., 2014; Fang et al., 2016).
In this study, we will be testing the potential for TVS to increase well-being (subjective calmness, increased performance, and physiological reactivity) in the PTSD population. Positive results would suggest that reduction in symptomatology may be possible without effort, and in lieu of specific interventions with medications or psychotherapy. A wearable form of TVS technology will be examined in a real-world setting. We will use ambulatory assessment to detect physiological indications of stress unique to each user and to provide user-optimized TVS, examining whether it increases parasympathetic nervous system reactivity in response to stress, thus decreasing subjective stress just as a user's stress begins to increase.
Conditions
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Health Behavior
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
randomized, controlled factorial within subject design
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
On-demand intervention was provided on only some physiologically detected stress events
Study Groups
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Stress incidents without TVS
a fraction of physiological detected stress incidents will not trigger TVS
Group Type
ACTIVE_COMPARATOR
no active intervention
Intervention Type
OTHER
No intervention will be administered
TVS in response to participant initiation or stress detection
The majority of detected stress incidents will trigger TVS. Participants can also trigger TVS voluntarily
Group Type
EXPERIMENTAL
Tuned Vibroacoustic Stimulation (TVS)
Intervention Type
OTHER
TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance
Interventions
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Tuned Vibroacoustic Stimulation (TVS)
TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance
Intervention Type
OTHER
no active intervention
No intervention will be administered
Intervention Type
OTHER
Eligibility Criteria
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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
* 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).
* 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).
Minimum Eligible Age
18 Years
Maximum Eligible Age
58 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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University of Pittsburgh
OTHER
Sponsor Role
lead
Responsible Party
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Greg Siegle
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Greg Siegle, MD
Role: PRINCIPAL_INVESTIGATOR
Western Psychiatric Institute and Clinic
Locations
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Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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PRO17110107
Identifier Type: -
Identifier Source: org_study_id
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ACTIVE_NOT_RECRUITING
NA
Use of a Novel Neuroplasticity-based Neurobehavioral Intervention for PTSD
NCT01694316
COMPLETED
NA
Investigation of the Freespira Breathing System in the Treatment of Post Traumatic Stress Disorder (PTSD)
NCT03039231
COMPLETED
NA
Integrated PTSD and Chronic Pain Treatment
NCT07225049
RECRUITING
NA
Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury
NCT00270959
COMPLETED
PHASE1
Physiological Augmentation of Mindfulness Meditation
NCT02754557
COMPLETED
NA
Responsive Neurostimulation for Post-Traumatic Stress Disorder
NCT04152993
RECRUITING
EARLY_PHASE1
Targeted Plasticity Therapy for PTSD
NCT06266364
RECRUITING
NA
Blended Treatment för PTSD Feasibility Study
NCT04881643
COMPLETED
NA
Trauma-focused Psychodynamic Psychotherapy for LGBT Patients With Post-traumatic Stress Disorder
NCT04532996
COMPLETED
NA
Non Invasive Brain Stimulation for PTSD
NCT02442843
COMPLETED
EARLY_PHASE1
Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot
NCT05112003
COMPLETED
NA
Neurofeedback for Post-Traumatic Stress Disorder
NCT05123690
RECRUITING
NA
Post-traumatic Stress Disorder Treatment Using Transcranial Direct Current Stimulation (tDCS) Enhancement of Trauma-focused Therapy : a Two-arm Randomized Controlled Multicentric Study.
NCT02900053
COMPLETED
NA
Neurofeedback With Real-Time fMRI for Treatment of PTSD
NCT03243149
WITHDRAWN
NA
EEG Biofeedback Therapy as an Adjunct Treatment for PTSD
NCT01591408
COMPLETED
NA
Deep Brain Stimulation for Treatment Refractory PTSD
NCT03416894
ACTIVE_NOT_RECRUITING
NA
Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)
NCT01507948
COMPLETED
NA
An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms
NCT06523023
NOT_YET_RECRUITING
NA
Theta-Burst Neuromodulation for PTSD
NCT02769312
COMPLETED
PHASE1/PHASE2
Software as a Medical Device for the Treatment of Patients With PTSD
NCT06589505
RECRUITING
PHASE2/PHASE3