Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Post Traumatic Stress Disorder
  • PTSD
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomized to either the experimental or sham arms.Masking: Double (Participant, Investigator)Masking Description: Participants will be randomly assigned to either the experimental or sham-control arms under double-blind conditions.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

Description

The purpose of this study is to examine the mechanisms of real-time fMRI (rt-fMRI) neurofeedback as a method by which to regulate functional brain connections underlying symptoms/emotions experienced by individuals with PTSD. The aim of this study is to evaluate further the suitability of state-of-t...

The purpose of this study is to examine the mechanisms of real-time fMRI (rt-fMRI) neurofeedback as a method by which to regulate functional brain connections underlying symptoms/emotions experienced by individuals with PTSD. The aim of this study is to evaluate further the suitability of state-of-the-art fMRI as a non-invasive therapeutic tool among individuals burdened by PTSD, in order to inform future clinical trials of neurofeedback aiming to reduce symptoms of PTSD. This will be achieved by using rt-fMRI and neurofeedback of brain signals, in order to teach individuals with PTSD to self-regulate the neural networks that are associated with their symptoms. Investigators will examine the mechanisms of self-regulating neural networks using real-time neuroimaging and feedback to these brain signals. Neurofeedback is a form of brain training that allows individuals to improve their health by learning to control signals from their own body. This study will employ a 2 (PTSD group vs. healthy control group) by 2 (arm; experimental vs. sham-control) design. This study involves an assessment which will include clinical interviews and a fMRI (functional magnetic resonance imaging) scan. The fMRI scan will involve trauma-word exposure during neurofeedback task runs. During the presentation of the words in the fMRI scanner, participants in the experimental arm will be able to view a feedback display that informs them of the strength of connectivity between the target regions. Participants in the sham-control arm will receive yoked sham neurofeedback signal (or fake signal), corresponding to a replayed feedback signal from a successful participant in the experimental group in order to ensure similar motivational states and following standard methods. In both arms, feedback signals will be relayed back to the participant in the scanner through visualization software as a thermometer that increases or decreases as the extent to which the target model dominates.

Tracking Information

NCT #
NCT04875221
Collaborators
Not Provided
Investigators
Principal Investigator: Ruth A Lanius, MD, PhD Lawson Health Research Institute