Stress Disorders, Post-TraumaticNCT02500719
Real-time fMRI and Neurofeedback of Brain Networks Mediating Trauma Memory Recall in PTSD
A study testing Computational Model - Real-time Support Vector Machine in people with Stress Disorders, Post-Traumatic, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of the current study is to develop a better understanding of the brain mechanisms involved in psychological treatments for posttraumatic stress disorder (PTSD). This project will build on past research using script-driven imagery in our lab by investigating brain activity in areas activated during exposure… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Computational Model - Real-time Support Vector Machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 21-50
- Medically healthy
Who cannot join
- Claustrophobia, or the inability to lie still in a confined space
- Major medical disorders (e.g., HIV, cancer)
- Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents)
- Electronic or magnetic implants, such as pacemakers
- Permanent makeup or tattoos with metallic dyes
- Currently pregnant
Show all 10Show fewer
- A self-reported history of loss of consciousness (greater than 10 minutes)
- Physical disabilities that prohibit task performance (such as blindness or deafness)
- Psychotic disorders (e.g., schizophrenia)
- Any other condition that the investigator believes might put the participant at risk
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Real-time Functional MRI and Neurofeedback of Brain Networks Mediating Trauma Memory Recall in PTSD
The purpose of the current study is to develop a better understanding of the brain mechanisms involved in psychological treatments for posttraumatic stress disorder (PTSD). This project will build on past research using script-driven imagery in our lab by investigating brain activity in areas activated during exposure to trauma-related cues. This project will also develop new knowledge concerning volitional control of those areas. The ultimate goal of this study is a better understanding of whether volitional control of these brain areas will improve therapeutic outcomes. This process will first be piloted in a sample of healthy controls. This will allow investigators to refine the methodology prior to recruiting a sample with PTSD.
Read the detailed description
Post-traumatic stress disorder (PTSD) is characterized by intense emotional distress upon exposure to trauma reminders and avoidance of people and places that can trigger the trauma memory. Neurocircuitry models of PTSD that seek to explain symptoms of heightened emotional reactivity, hypervigilance for threat, and avoidance suggest abnormal activity of neural regions involved in emotional reactivity (e.g., amygdala) and cognitive control of emotional responding (e.g., ventral medial prefrontal cortex, anterior cingulate cortex). While knowledge exists about neurobiological abnormalities associated with PTSD, these data are cross-sectional in nature and ignore individual differences in both neural encoding and subjective aspects of the trauma itself (e.g., whether it elicits fear vs guilt vs disgust). Additionally, the manner by which existing psychological treatments alter these neural mechanisms mediating core PTSD symptoms is unknown. This is problematic, given that state-of-the-art treatment for PTSD is only effective ~60% of the time.
Here, the investigator proposes to utilize a novel computational modeling approach combined with state-of-the-art functional magnetic resonance imaging (fMRI)-based neurofeedback to directly identify and modulate the idiosyncratic neural network encoding the trauma memory. Successful pursuit of these aims would 1) provide scientific support for the hypothesis that a distributed network including the amygdala, hippocampus, medial prefrontal cortex (PFC), lateral PFC, and anterior insula mediates emotional responding upon trauma memory recall, and 2) provide proof-of-concept evidence that neurofeedback modulation of this network can boost existing therapy efficacy.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Computational Model - Real-time Support Vector Machine
- Keywords
- Post-Traumatic Stress Disorder, Neurofeedback, fMRI, Skin Conductance Response
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computational Model - Real-time Support Vector MachineDevice
Also called Machine Learning Algorithm, Real-time Neurofeedback
A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory (note, this is equivalent to predictions of fitted Q-iteration in which the all actions are specified as zero, reward is equal to the support vector machine predicted arousal, and the discount factor of 0). The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants | Experimental | A group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal. Receives: Device: Computational Model - Real-time Support Vector Machine |
| PTSD Participants | Experimental | A group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks. Receives: Device: Computational Model - Real-time Support Vector Machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not.
Support vector machine decodings of functional MRI data acquired during volitional engagement or disengagement of emotional arousal. Each decoding represents the Euclidean distance and direction (either positive or negative) of the functional MRI data volume with respect to the patient's support vector machine decision hyperplane. Positive distances denote engagement of emotional arousal and negative distances denote disengagement of emotion arousal. Distance represents the magnitude of volitional engagement or disengagement. Decodings can either be provided to patients as real-time neurofeedback (via visual representation of the distance) or hidden from view. When hidden, the visual representation of neurofeedback remains stationary.
Measured: Real-time within the measurement of functional MRI (within 10 seconds of functional MRI volume acquisition and reconstruction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study start15 Aug 2015
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Bush, PhD., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500719
- Sponsor's protocol ID
- 203600
- Status last verified
- Apr 2021
- First submitted
- 7 Jul 2015
- Last updated
- 20 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Functional MRI and Neurofeedback of Brain Networks Mediating Trauma Memory Recall in PTSD
- ClinicalTrials.gov ID
- NCT02500719
- Acronym / sponsor ID
- 203600
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Post-Traumatic Stress Disorder, Neurofeedback, fMRI, Skin Conductance Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 20 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to develop a better understanding of the brain mechanisms involved in psychological treatments for posttraumatic stress disorder (PTSD). This project will build on past research using script-driven imagery in our lab by investigating brain activity in areas activated during exposure to trauma-related cues. This project will also develop new knowledge concerning volitional control of those areas. The ultimate goal of this study is a better understanding of whether volitional control of these brain areas will improve therapeutic outcomes. This process will first be piloted in a sample of healthy controls. This will allow investigators to refine the methodology prior to recruiting a sample with PTSD.
Detailed description
Post-traumatic stress disorder (PTSD) is characterized by intense emotional distress upon exposure to trauma reminders and avoidance of people and places that can trigger the trauma memory. Neurocircuitry models of PTSD that seek to explain symptoms of heightened emotional reactivity, hypervigilance for threat, and avoidance suggest abnormal activity of neural regions involved in emotional reactivity (e.g., amygdala) and cognitive control of emotional responding (e.g., ventral medial prefrontal cortex, anterior cingulate cortex). While knowledge exists about neurobiological abnormalities associated with PTSD, these data are cross-sectional in nature and ignore individual differences in both neural encoding and subjective aspects of the trauma itself (e.g., whether it elicits fear vs guilt vs disgust). Additionally, the manner by which existing psychological treatments alter these neural mechanisms mediating core PTSD symptoms is unknown. This is problematic, given that state-of-the-art treatment for PTSD is only effective ~60% of the time.
Here, the investigator proposes to utilize a novel computational modeling approach combined with state-of-the-art functional magnetic resonance imaging (fMRI)-based neurofeedback to directly identify and modulate the idiosyncratic neural network encoding the trauma memory. Successful pursuit of these aims would 1) provide scientific support for the hypothesis that a distributed network including the amygdala, hippocampus, medial prefrontal cortex (PFC), lateral PFC, and anterior insula mediates emotional responding upon trauma memory recall, and 2) provide proof-of-concept evidence that neurofeedback modulation of this network can boost existing therapy efficacy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants | Experimental | Device: Computational Model - Real-time Support Vector MachineA group of healthy participants will be enrolled first in the pilot phase of the study. This phase allows for the refinement (prior to the implementing in our PTSD participant group) the application of our support vector machine based real-time functional magnetic resonance imaging (rt-fMRI) algorithm, which evaluates brain networks thought to mediate emotional arousal and presents them (in real time) to subjects to aide in volitional manipulation of arousal. |
| PTSD Participants | Experimental | Device: Computational Model - Real-time Support Vector MachineA group of participants with symptoms of PTSD will be enrolled in the implementation phase of the study. This phase allows for the evaluation of rt-fMRI guidance of brain networks thought to mediate emotional arousal, specifically whether participants can learn volitional control of these networks. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Aged 21-50
- Medically healthy
Key exclusion criteria (10 listed)
- Claustrophobia, or the inability to lie still in a confined space
- Major medical disorders (e.g., HIV, cancer)
- Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents)
- Electronic or magnetic implants, such as pacemakers
- Permanent makeup or tattoos with metallic dyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computational Model - Real-time Support Vector MachineAlso: Machine Learning Algorithm, Real-time NeurofeedbackA support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory (note, this is equivalent to predictions of fitted Q-iteration in which the all actions are specified as zero, reward is equal to the support vector machine predicted arousal, and the discount factor of 0). The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group. | Device | Healthy Participants, PTSD Participants |
Primary outcome
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not.
Time frame: Real-time within the measurement of functional MRI (within 10 seconds of functional MRI volume acquisition and reconstruction)
Support vector machine decodings of functional MRI data acquired during volitional engagement or disengagement of emotional arousal. Each decoding represents the Euclidean distance and direction (either positive or negative) of the functional MRI data volume with respect to the patient's support vector machine decision hyperplane. Positive distances denote engagement of emotional arousal and negative distances denote disengagement of emotion arousal. Distance represents the magnitude of volitional engagement or disengagement. Decodings can either be provided to patients as real-time neurofeedback (via visual representation of the distance) or hidden from view. When hidden, the visual representation of neurofeedback remains stationary.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Bush, PhD. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computational Model - Real-time Support Vector Machine in people with Stress Disorders, Post-Traumatic, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Emotional Response to Volitional Engagement and Disengagement of Emotional Arousal as Measured Using Support Vector Machine Decodings When the Decoding is Provided as Real-time Neurofeedback Guidance or Not. (time frame: Real-time within the measurement of functional MRI (within 10 seconds of functional MRI volume acquisition and reconstruction)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2021.