Clinical trial NCT04875221: Network-based Neurofeedback in PTSD
Official title: Mechanisms of Network-based Real-time fMRI Neurofeedback in Patients With Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: PTSD
Post-traumatic Stress Disorder
Keywords: Neurofeedback
NFB
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the experimental or sham arms.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation
timeFrame: 1hour
measure: Changes in emotional experience over neurofeedback training (RSDI scale)
timeFrame: 1-week
Secondary outcomes:
measure: Changes in PTSD symptoms over neurofeedback training (PCL-5)
timeFrame: 1-week
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Onatrio
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Ruth A Lanius, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: