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Neurofeedback With Real-Time fMRI for Treatment of PTSD

NCT ID: NCT03243149

Last Updated: 2022-12-21

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-01-31

Brief Summary

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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

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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

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will be unaware of whether the thermometer ratings they see while in the scanner are false feedback consisting of noise or true activation.

Study Groups

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False Feedback

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.

Group Type SHAM_COMPARATOR

fMRI - GE Medical System

Intervention Type DEVICE

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.

View Condition

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.

Group Type ACTIVE_COMPARATOR

fMRI - GE Medical System

Intervention Type DEVICE

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.

Free Regulate

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.

Group Type EXPERIMENTAL

fMRI - GE Medical System

Intervention Type DEVICE

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.

Interventions

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fMRI - GE Medical System

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.

Intervention Type DEVICE

Other Intervention Names

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Neurofeedback regulation of fear extinction neurocircuitry

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rajendra A Morey, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00081664

Identifier Type: -

Identifier Source: org_study_id