Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875221
Status:
WITHDRAWN
Last Update Posted:
2023-09-21
First Post:
2021-04-27
Brief Title:
Network-based Neurofeedback in PTSD
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
Mechanisms of Network-based Real-time fMRI Neurofeedback in Patients With Posttraumatic Stress Disorder
Status:
WITHDRAWN
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study is no longer being conducted by Dr Lanius - the principal investigator has been changed from Dr Ruth Lanius to Dr Andrew Nicholson
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 symptomsemotions 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None