Network-based Neurofeedback in PTSD

NCT ID: NCT04875221

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-09-30

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental neurofeedback arm

The experimental arm will be able to view a feedback display that informs them of the strength of connectivity between the target regions. 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 neural target model dominates (in other words, as the strength of directed connectivity between regions increases).

Group Type: EXPERIMENTAL

Connectivity-based neurofeedback

Intervention Type: COMBINATION_PRODUCT

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.

Sham-control neurofeedback arm

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.

Group Type: SHAM_COMPARATOR

Connectivity-based neurofeedback

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

PTSD Group:

• English speaking
• age: 18-65
• meets diagnostic criteria for PTSD (as determined by study assessment)

Control Group:

• English speaking
• age: 18-65

Exclusion Criteria

All participants:

• Individuals with any implants, conditions, etc. that do not comply with 3-Tesla fMRI research safety standards (e.g., certain implants, pregnancy)
• history of neurological disorder
• history of any pervasive developmental disorder
• history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident assessed retrospectively by participant)
• significant untreated medical illness
• alcohol/substance abuse or dependence within the last 3 months

PTSD Group:

• history of bipolar disorder
• history of psychosis
• extensive current use of narcotic medications

Control Group:

• any current or past mental health disorders
• extensive current or past psychotherapy
• extensive current or past use of psychotropic or narcotic medications

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Ruth Lanius

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruth A Lanius, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

London Health Sciences Centre - University Hospital

London, Onatrio, Canada

Countries

Canada

Other Identifiers

9004

Identifier Type: -

Identifier Source: org_study_id