Neurofeedback With Real-Time fMRI for Treatment of PTSD

NCT03243149 | Withdrawn DMC FDA Device

• 1 other identifier: Pro00081664
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.

Secondary Outcomes (6)

• Change in psychophysiological data

  Baseline scan (week 1), week 2, week 3, week 4, week 5 and week 6.

• Change in Clinician Administered PTSD Scale (CAPS) Severity Score

  Baseline, 6 weeks

• Beck Depression Inventory-II (BDI-II)

  Baseline

• Drug Abuse Screening Test (DAST)

  Baseline

• Combat Exposure Scale (CES)

  Baseline

Study Arms (3)

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.

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.

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.

Device: fMRI - GE Medical System

Interventions

fMRI - GE Medical System 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.

Also known as: Neurofeedback regulation of fear extinction neurocircuitry

False Feedback; Free Regulate; View Condition

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fluent in English and capable of informed consent
• free of implanted metal objects
• years of age
• Antidepressant sleep and anti-anxiety medication use is permitted

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rajendra A Morey, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of whether the thermometer ratings they see while in the scanner are false feedback consisting of noise or true activation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: July 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

US (1)