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Network-based Neurofeedback in PTSD

Primary Purpose

PTSD, Post-traumatic Stress Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Connectivity-based neurofeedback
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Neurofeedback, NFB

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental neurofeedback arm

Sham-control neurofeedback arm

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Changes in PTSD symptoms over neurofeedback training (PCL-5)
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. Investigators will evaluate changes in PTSD symptoms from baseline, to post-neurofeedback training and at 1-week follow-up using the PCL-5. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).

Full Information

First Posted
April 27, 2021
Last Updated
September 18, 2023
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04875221
Brief Title
Network-based Neurofeedback in PTSD
Official Title
Mechanisms of Network-based Real-time fMRI Neurofeedback in Patients With Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study is no longer being conducted by Dr. Lanius - the principal investigator has been changed from Dr. Ruth Lanius to Dr. Andrew Nicholson.
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Post-traumatic Stress Disorder
Keywords
Neurofeedback, NFB

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either the experimental or sham arms.
Masking
ParticipantInvestigator
Masking Description
Participants will be randomly assigned to either the experimental or sham-control arms under double-blind conditions.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental neurofeedback arm
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham-control neurofeedback arm
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Connectivity-based neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in functional magnetic resonance imaging (fMRI) neural connectivity/activation
Description
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).
Time Frame
1hour
Title
Changes in emotional experience over neurofeedback training (RSDI scale)
Description
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).
Time Frame
1-week
Secondary Outcome Measure Information:
Title
Changes in PTSD symptoms over neurofeedback training (PCL-5)
Description
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses symptoms of PTSD. The PCL-5 has a variety of purposes, including monitoring symptom change during and after treatment. Investigators will evaluate changes in PTSD symptoms from baseline, to post-neurofeedback training and at 1-week follow-up using the PCL-5. The minimum score is 0, the maximum is 80 (higher scores indicate increased PTSD severity).
Time Frame
1-week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruth A Lanius, MD, PhD
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre - University Hospital
City
London
State/Province
Onatrio
ZIP/Postal Code
N6A 5A5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Network-based Neurofeedback in PTSD

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