PTSDNCT03243149
Neurofeedback With Real-Time fMRI for Treatment of PTSD
A study testing fMRI - GE Medical System in people with PTSD, run by Duke University at 1 site in United States.
Trial summary
PTSD is a debilitating and costly condition and currently available treatment options have risks and limitations that necessitate development of novel interventions. Collectively, the functional brain imaging reports suggest that patients with PTSD, especially those with the re-experiencing and hypervigilence… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- fMRI - GE Medical System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in English and capable of informed consent
- free of implanted metal objects
- 18-50 years of age
- Antidepressant sleep and anti-anxiety medication use is permitted
Who cannot join
- Claustrophobia
- Neurological disorders, History of learning disability or developmental delay
- Current substance abuse or history of substance dependence
- Psychotic disorders
- Significant medical conditions
- Current suicidality or attempt within the previous year
Show all 10Show fewer
- History of neurological injury or disease
- Pregnancy
- Major Axis 1 Psychiatric Disorders (exceptions are unipolar depression, past substance abuse, current or past nicotine dependence)
- Metal in the body
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Neurofeedback With Real-Time fMRI for Treatment of Posttraumatic Stress Disorder
PTSD is a debilitating and costly condition and currently available treatment options have risks and limitations that necessitate development of novel interventions. Collectively, the functional brain imaging reports suggest that patients with PTSD, especially those with the re-experiencing and hypervigilence phenotype, show ventromedial PFC hypoactivation and amygdala hyperactivation in response to symptom provocation, and that treatment, when successful is associated with reduced amygdala and increased ventromedial PFC activation. This project is guided by a neurocircuit model of PTSD dysfunction in which abnormalities in fronto-limbic imbalance, which diminishes capacity for fear extinction learning, and produces PTSD symptoms of re-experiencing and hyperarousal. Thus, our studies aim to bridge the translational gap between theoretical and neurobiological models of PTSD to implementation of clinical practice. The Target Engagement and Dosing Phase of this project, which is a pilot study, will demonstrate target engagement and its association with laboratory measures of PTSD-relevant neural processes.
Read the detailed description
The proposed treatment is expected to reduce symptoms of PTSD particularly re-experiencing and hyperarousal symptoms. These improvements in symptoms are expected to translate into improved social and occupational function for subjects with PTSD.
Specific Aim 1: The investigators will test (1) the efficacy of neurofeedback in subjects with PTSD attempting to upregulate ventral medial PFC and simultaneously downregulate amygdala, and (2) determine the number of neurofeedback sessions (dose) needed for target engagement and transfer. Prior to the neurofeedback training, participants' baseline ability to regulate in the absence of neurofeedback from real-time fMRI will be ascertained. Then during session, participants will receive veridical real-time feedback in the scanner indicating the activation level of ventromedial PFC minus amygdala. Participants will attempt to regulate to achieve a predetermined target level known to the participant. Neurofeedback conditions will include (1) false feedback (sham) shows a thermometer that indicates false feedback consisting of noise, (2) view condition shows a thermometer that indicates true activation of ventromedial PFC minus amygdala but the participant is asked not to attempt neuroregulation, (3) free regulate shows a thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation. The investigators will enroll 10 participants who will engage in a six weekly neurofeedback sessions to assess target engagement and dosing.
Specific Aim 2: The ability for participants to regulate will be further challenged by explicit exposure to trauma relevant stimuli that elicit increased amygdala activation in patients with PTSD. The investigators will follow the same procedure as the previous aim except that free regulate condition (condition #3) will be replaced with conditions (4) trauma regulate shows a participant-specific trauma-relevant image and the thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation, and (5) neutral regulate shows a trauma-unrelated image and the thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation. The investigators will enroll 10 participants who will engage in a six weekly neurofeedback sessions to assess target engagement and dosing.
Participants will be assessed for PTSD and related symptoms before and after to the 6-week intervention using the Clinician Administered PTSD Scale (CAPS) (Appendix XVI) and Beck Depression Inventory (BDI-II) (Appendix IX). The investigators hypothesize enhanced neuroregulation and transfer will be associated with a concomitant reduction in PTSD severity and lower comorbid anxiety symptoms.
Specific Aim 3: Participants will be assessed before and after the 6-week intervention with a brief neurocognitive battery of episodic memory, working memory, executive function, and sustained attention. The investigators hypothesize that successful neuroregulation and transfer will be associated with concomitant cognitive performance improvements.
- Conditions
- PTSD
- Being tested
- fMRI - GE Medical System
- 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.
fMRI - GE Medical SystemDevice
Also called Neurofeedback regulation of fear extinction neurocircuitry
Recovery from PTSD symptoms has been modeled experimentally as fear extinction that depends on three interconnected brain regions that involve the amygdala where extinction memories are stored, the subcallosal/subgenual cortex within the medial PFC involved in consolidation of the extinction memory, and the hippocampus which mediates the context specificity of context specificity of extinction.
The two MRI systems are used for human research by many faculty and research groups at Duke and UNC, Chapel Hill. The center has two research dedicated General Electric MR 750 scanners with a field strength of 3 Tesla. These systems use a combination of General Electric production pulse sequences and custom research pulse sequences that have been developed by Brain Imaging and Analysis Center faculty and other MR physicists. The scanners are used for imaging and spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| False Feedback | Sham comparator | Neurofeedback from real-time acquired images (fMRI - GE Medical System) will be shown to subjects. False feedback (sham) shows a thermometer that indicates false feedback consisting of noise. Receives: Device: fMRI - GE Medical System |
| View Condition | Active comparator | Neurofeedback from real-time acquired images (fMRI - GE Medical System) will be shown to subjects. View condition shows a thermometer that indicates true activation of ventromedial PFC minus amygdala but the participant is asked not to attempt neuroregulation. Receives: Device: fMRI - GE Medical System |
| Free Regulate | Experimental | Neurofeedback from real-time acquired images (fMRI - GE Medical System) will be shown to subjects. Free regulate shows a thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation. Receives: Device: fMRI - GE Medical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MRI Imaging Acquisition
fMRI scans will use a 3T GE scanner at the Duke-UNC Brain Imaging and Analysis Center. Structural MRI data and functional MRI data that includes real-time feedback on the participants brain activity will be made available to the participant to facilitate self-regulation.
Participants will begin and end each scanning session with a 6-minute resting-state scan. The purpose of the first resting-state run is collect pre-Training baseline resting-state activation and to acclimate the subject to the scanner environment prior to neuroregulatory training. The purpose of the second resting state run is examine changes in functional connectivity after compared to before real-time fMRI neurofeedback.
To determine the effect of session on subject ability to increases ventromedial prefrontal cortex activation and decrease amygdala activation and establish a dose-response relationship for neuroregulation, we will measure changes in BOLD signal across scan sessions.
Measured: Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.
Secondary outcomes (6)
Change in psychophysiological data
Physiological measures of heart rate and respiration will be recorded during each scan, using an MR-safe commercial system (MP-150 BIOPAC systems, Goleta, CA) to permit removal of physiological noise from the fMRI signal. To evaluate potential scalable non-fMRI correlates, we will also acquire pupillometry using an MR-compatible camera (Arrington Research, Inc.) and galvanic skin conductance levels to identify fear or anxiety responses that impede self-activation.
To determine the effect of session on subject ability to regulate stress through neurofeedback, we will measure changes in psychophysiological data across scan sessions.
Measured: Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.
Change in Clinician Administered PTSD Scale (CAPS) Severity Score
Participants will be assessed for current and lifetime PTSD twice, once at the beginning and once at the end of the 6 weeks.
Measured: Baseline, 6 weeks
Beck Depression Inventory-II (BDI-II)
Diagnostic assessment for PTSD and comorbid symptoms of depression
Measured: Baseline
Drug Abuse Screening Test (DAST)
Diagnostic assessment for substance use
Measured: Baseline
Combat Exposure Scale (CES)
Diagnostic assessment for combat exposure.
Measured: Baseline
Deployment Risk and Resilience Inventory-2 (DRRI-2)
Baseline diagnostic assessment for both risk and resilience.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study start1 Jul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Why it stopped: Insufficient staff and equipment challenges
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will test (1) the efficacy of neurofeedback in subjects with PTSD attempting to upregulate ventral medial PFC and simultaneously downregulate amygdala, and (2) determine the number of neurofeedback sessions (dose) needed for target engagement and transfer. Prior to the neurofeedback training, participants' baseline ability to regulate in the absence of neurofeedback from real-time fMRI will be ascertained. Then during session, participants will receive veridical real-time feedback in the scanner indicating the activation level of ventromedial PFC minus amygdala. Participants will attempt to regulate to achieve a predetermined target level known to the participant.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rajendra A Morey, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243149
- Sponsor's protocol ID
- Pro00081664
- Status last verified
- Dec 2022
- First submitted
- 4 Aug 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Except when required by law, the investigators will not identify subjects by name, social security number, address, telephone number, or any other personal identifier in study records disclosed outside DUMC. For records disclosed outside DUMC, only the subjects' identification numbers will be used. Coded data that includes MRI images, MRI task based responses, psychometric, and diagnostic information will be released to collaborating investigators. The study results will be retained in subjects' research records for an indefinite time after completion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback With Real-Time fMRI for Treatment of Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT03243149
- Acronym / sponsor ID
- Pro00081664
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient staff and equipment challenges
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 8 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PTSD is a debilitating and costly condition and currently available treatment options have risks and limitations that necessitate development of novel interventions. Collectively, the functional brain imaging reports suggest that patients with PTSD, especially those with the re-experiencing and hypervigilence phenotype, show ventromedial PFC hypoactivation and amygdala hyperactivation in response to symptom provocation, and that treatment, when successful is associated with reduced amygdala and increased ventromedial PFC activation. This project is guided by a neurocircuit model of PTSD dysfunction in which abnormalities in fronto-limbic imbalance, which diminishes capacity for fear extinction learning, and produces PTSD symptoms of re-experiencing and hyperarousal. Thus, our studies aim to bridge the translational gap between theoretical and neurobiological models of PTSD to implementation of clinical practice. The Target Engagement and Dosing Phase of this project, which is a pilot study, will demonstrate target engagement and its association with laboratory measures of PTSD-relevant neural processes.
Detailed description
The proposed treatment is expected to reduce symptoms of PTSD particularly re-experiencing and hyperarousal symptoms. These improvements in symptoms are expected to translate into improved social and occupational function for subjects with PTSD.
Specific Aim 1: The investigators will test (1) the efficacy of neurofeedback in subjects with PTSD attempting to upregulate ventral medial PFC and simultaneously downregulate amygdala, and (2) determine the number of neurofeedback sessions (dose) needed for target engagement and transfer. Prior to the neurofeedback training, participants' baseline ability to regulate in the absence of neurofeedback from real-time fMRI will be ascertained. Then during session, participants will receive veridical real-time feedback in the scanner indicating the activation level of ventromedial PFC minus amygdala. Participants will attempt to regulate to achieve a predetermined target level known to the participant. Neurofeedback conditions will include (1) false feedback (sham) shows a thermometer that indicates false feedback consisting of noise, (2) view condition shows a thermometer that indicates true activation of ventromedial PFC minus amygdala but the participant is asked not to attempt neuroregulation, (3) free regulate shows a thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation. The investigators will enroll 10 participants who will engage in a six weekly neurofeedback sessions to assess target engagement and dosing.
Specific Aim 2: The ability for participants to regulate will be further challenged by explicit exposure to trauma relevant stimuli that elicit increased amygdala activation in patients with PTSD. The investigators will follow the same procedure as the previous aim except that free regulate condition (condition #3) will be replaced with conditions (4) trauma regulate shows a participant-specific trauma-relevant image and the thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation, and (5) neutral regulate shows a trauma-unrelated image and the thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation. The investigators will enroll 10 participants who will engage in a six weekly neurofeedback sessions to assess target engagement and dosing.
Participants will be assessed for PTSD and related symptoms before and after to the 6-week intervention using the Clinician Administered PTSD Scale (CAPS) (Appendix XVI) and Beck Depression Inventory (BDI-II) (Appendix IX). The investigators hypothesize enhanced neuroregulation and transfer will be associated with a concomitant reduction in PTSD severity and lower comorbid anxiety symptoms.
Specific Aim 3: Participants will be assessed before and after the 6-week intervention with a brief neurocognitive battery of episodic memory, working memory, executive function, and sustained attention. The investigators hypothesize that successful neuroregulation and transfer will be associated with concomitant cognitive performance improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The investigators will test (1) the efficacy of neurofeedback in subjects with PTSD attempting to upregulate ventral medial PFC and simultaneously downregulate amygdala, and (2) determine the number of neurofeedback sessions (dose) needed for target engagement and transfer. Prior to the neurofeedback training, participants' baseline ability to regulate in the absence of neurofeedback from real-time fMRI will be ascertained. Then during session, participants will receive veridical real-time feedback in the scanner indicating the activation level of ventromedial PFC minus amygdala. Participants will attempt to regulate to achieve a predetermined target level known to the participant.
| Arm | Type | Receives |
|---|---|---|
| False Feedback | Sham comparator | Device: fMRI - GE Medical SystemNeurofeedback from real-time acquired images (fMRI - GE Medical System) will be shown to subjects. False feedback (sham) shows a thermometer that indicates false feedback consisting of noise. |
| View Condition | Active comparator | Device: fMRI - GE Medical SystemNeurofeedback from real-time acquired images (fMRI - GE Medical System) will be shown to subjects. View condition shows a thermometer that indicates true activation of ventromedial PFC minus amygdala but the participant is asked not to attempt neuroregulation. |
| Free Regulate | Experimental | Device: fMRI - GE Medical SystemNeurofeedback from real-time acquired images (fMRI - GE Medical System) will be shown to subjects. Free regulate shows a thermometer that indicates true activation of ventromedial PFC minus amygdala while the participant attempts neuroregulation. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fluent in English and capable of informed consent
- free of implanted metal objects
- 18-50 years of age
- Antidepressant sleep and anti-anxiety medication use is permitted
Key exclusion criteria (10 listed)
- Claustrophobia
- Neurological disorders, History of learning disability or developmental delay
- Current substance abuse or history of substance dependence
- Psychotic disorders
- Significant medical conditions
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 |
|---|---|---|
| fMRI - GE Medical SystemAlso: Neurofeedback regulation of fear extinction neurocircuitryRecovery from PTSD symptoms has been modeled experimentally as fear extinction that depends on three interconnected brain regions that involve the amygdala where extinction memories are stored, the subcallosal/subgenual cortex within the medial PFC involved in consolidation of the extinction memory, and the hippocampus which mediates the context specificity of context specificity of extinction. The two MRI systems are used for human research by many faculty and research groups at Duke and UNC, Chapel Hill. The center has two research dedicated General Electric MR 750 scanners with a field strength of 3 Tesla. These systems use a combination of General Electric production pulse sequences and custom research pulse sequences that have been developed by Brain Imaging and Analysis Center faculty and other MR physicists. The scanners are used for imaging and spectroscopy. | Device | False Feedback, Free Regulate, View Condition |
Primary outcome
Change in MRI Imaging Acquisition
Time frame: Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.
fMRI scans will use a 3T GE scanner at the Duke-UNC Brain Imaging and Analysis Center. Structural MRI data and functional MRI data that includes real-time feedback on the participants brain activity will be made available to the participant to facilitate self-regulation. Participants will begin and end each scanning session with a 6-minute resting-state scan. The purpose of the first resting-state run is collect pre-Training baseline resting-state activation and to acclimate the subject to the scanner environment prior to neuroregulatory training. The purpose of the second resting state run is examine changes in functional connectivity after compared to before real-time fMRI neurofeedback. To determine the effect of session on subject ability to increases ventromedial prefrontal cortex activation and decrease amygdala activation and establish a dose-response relationship for neuroregulation, we will measure changes in BOLD signal across scan sessions.
6 secondary outcomes
Change in psychophysiological data
Time frame: Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.
Change in Clinician Administered PTSD Scale (CAPS) Severity Score
Time frame: Baseline, 6 weeks
Beck Depression Inventory-II (BDI-II)
Time frame: Baseline
Drug Abuse Screening Test (DAST)
Time frame: Baseline
Combat Exposure Scale (CES)
Time frame: Baseline
Deployment Risk and Resilience Inventory-2 (DRRI-2)
Time frame: Baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Individual participant dataSharing planned: Undecided. Except when required by law, the investigators will not identify subjects by name, social security number, address, telephone number, or any other personal identifier in study records disclosed outside DUMC. For records disclosed outside DUMC, only the subjects' identification numbers will be used. Coded data that includes MRI images, MRI task based responses, psychometric, and diagnostic information will be released to collaborating investigators. The study results will be retained in subjects' research records for an indefinite time after completion of the study.
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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.
Rajendra A Morey, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI - GE Medical System in people with PTSD, run by Duke University 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 4 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: withdrawn, as of the sponsor's last update on 21 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in MRI Imaging Acquisition (time frame: Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.). 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 21 Dec 2022.