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Neurofeedback With Real-Time fMRI for Treatment of PTSD

NCT03243149 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-12-21

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

  • Rajendra A Morey, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-01-31
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03243149 on ClinicalTrials.gov