NCT04875221

Network-based Neurofeedback in PTSD

Mechanisms of Network-based Real-time fMRI Neurofeedback in Patients With Posttraumatic Stress Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This project will examine the use of real-time fMRI (rt-fMRI) neurofeedback in the regulation of neural networks underlying symptoms experienced by individuals with posttraumatic stress disorder (PTSD). Investigators will use rt-fMRI neurofeedback in order to facilitate emotion regulation during symptom induction, and examine individual differences that influence regulation capacities.

Detailed 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-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.

Conditions

• PTSD
• Post-traumatic Stress Disorder

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Connectivity-based neurofeedback	Real-time fMRI neurofeedback will be used to non-invasively regulate neural network connectivity patterns associated with symptoms and emotional arousal among patients with PTSD and healthy individuals, with the aim to induce lasting neuronal effects and reduce symptoms.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-09-01
• Completion: 2024-09-01
• First posted: 2021-05-06
• Last updated: 2023-09-21

Locations

1 site across 1 country: Canada