Network-based Neurofeedback in PTSD

NCT04875221 | Withdrawn

• 1 other identifier: 9004
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Post-traumatic Stress Disorder

Keywords

Neurofeedback; NFB

Outcome Measures

Primary Outcomes (2)

• Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation

  Investigators will evaluate changes in fMRI neural connectivity and activation as a function of neurofeedback treatment. Specifically, investigators will evaluate changes in fMRI neural connectivity/activity among brain areas included in the neurofeedback target network (which includes areas within the default mode, salience, and central executive networks).

  1hour

• Changes in emotional experience over neurofeedback training (RSDI scale)

  The Response to Script Driven Imagery (RSDI) Scale will assess changes in symptoms after each neurofeedback run in the scanner (3 training runs), in line with previous neurofeedback studies. Investigators will evaluate changes in emotional experience during neurofeedback treatment and at 1-week follow-up, using the RSDI scale. The RSDI has a minimum value of 0 and maximum value of 66 (higher scores indicate more severe symptoms/emotional distress).

  1-week

Secondary Outcomes (1)

• Changes in PTSD symptoms over neurofeedback training (PCL-5)

  1-week

Study Arms (2)

Experimental neurofeedback arm

EXPERIMENTAL

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).

Combination Product: Connectivity-based neurofeedback

Sham-control neurofeedback arm

SHAM COMPARATOR

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.

Combination Product: Connectivity-based neurofeedback

Interventions

Connectivity-based neurofeedback 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.

Experimental neurofeedback arm; Sham-control neurofeedback arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Onatrio, N6A 5A5, Canada

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Ruth A Lanius, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants will be randomly assigned to either the experimental or sham-control arms under double-blind conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to either the experimental or sham arms.

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 6, 2021
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)