60 Participants Needed

fMRI-Neurofeedback for PTSD

AA
JM
Overseen ByJonathan M Lieberman, BSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

Post-traumatic stress disorder (PTSD) is a debilitating and highly prevalent psychiatric disorder that develops in the aftermath of trauma exposure (APA, 2013). PTSD has been strongly associated with altered activation patterns within several large-scale brain networks and, as such, it has been suggested that normalizing pathological brain activation may be an effective treatment approach. The objective of this proposed study is to investigate the ability of PTSD patients to self-regulate aberrant neural circuitry associated with PTSD psychopathology using real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback. Here, the investigators are building upon previous single-session pilot studies examining the regulation of the amygdala and the posterior cingulate cortex (PCC) in PTSD (Nicholson et al., 2021) (Nicholson et al., 2016) by: (1) Examining the effect of multiple sessions of rt-fMRI neurofeedback and, (2) Comparing PCC- and amygdala-targeted rt-fMRI neurofeedback to sham-control groups with regards to changes in PTSD symptoms and neural connectivity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using chronic opioid analgesics or have active substance use issues, you may be excluded from participating.

What data supports the effectiveness of the treatment fMRI-Neurofeedback for PTSD?

Research shows that real-time fMRI neurofeedback can help people with PTSD, like war veterans, learn to control brain activity related to stress, leading to symptom improvements. A study found that two out of three veterans with chronic PTSD experienced meaningful symptom reduction, suggesting this treatment could be promising for PTSD.12345

Is fMRI neurofeedback safe for humans?

In a feasibility study with war veterans with PTSD, all participants tolerated the fMRI neurofeedback training well, suggesting it is generally safe for humans.23467

How does fMRI Neurofeedback treatment differ from other PTSD treatments?

fMRI Neurofeedback is unique because it uses real-time brain imaging to help patients learn to control specific brain regions, like the amygdala, which is involved in emotional responses. This approach is different from traditional PTSD treatments as it provides immediate feedback on brain activity, allowing patients to develop personalized strategies for managing their symptoms.12348

Eligibility Criteria

This trial is for English-speaking adults aged 18-65 with PTSD, comfortable with tech like laptops and smartphones. Participants must have a PTSD diagnosis as per DSM-5 criteria but can also have depression or anxiety disorders. Exclusions include pregnancy, serious illnesses, MRI contraindications (like metal implants), neurological issues, untreated major illnesses, substance abuse in the last three months, claustrophobia, prior neurofeedback therapy or brain stimulation treatments.

Inclusion Criteria

Fluent English speaker
Able to provide written informed consent
Comfortable using electronic devices (i.e., laptop, tablet, smartphone, etc.)
See 1 more

Exclusion Criteria

Meeting criteria for substance use disorder in the past three months
I am currently in therapy specifically for trauma.
History of claustrophobia
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Clinical Assessment

Baseline clinical assessments including MINI and CAPS-5 to establish mental health disorder diagnoses and PTSD symptom severity

1 week
1 visit (in-person)

Self-report Assessments

Participants complete a battery of self-report questionnaires via REDCap

1 week

rt-fMRI Neurofeedback Sessions

3 rt-fMRI neurofeedback sessions over 3 weeks, including pre-session RSDI, localization scan, anatomical scan, resting-state scan, and task runs

3 weeks
3 visits (in-person)

Actigraphy Monitoring

Participants wear actigraphy devices to monitor biological rhythms and physical activity

7 weeks

Follow-up

Participants are monitored for changes in PTSD symptoms, interoceptive awareness, emotion regulation, and other measures at a 1-month follow-up

4 weeks
1 visit (virtual)

Treatment Details

Interventions

  • MRI Biofeedback
  • Sham-MRI Biofeedback
Trial Overview The study tests if multiple sessions of real-time fMRI neurofeedback can help PTSD patients control abnormal brain activity linked to their condition. It compares two targets for feedback: the amygdala and posterior cingulate cortex against sham controls to see which affects symptoms and neural connectivity better.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Sham-controlExperimental Treatment1 Intervention
PTSD participants will receive a sham neurofeedback signal, i.e., from a successful participant in one of the experimental arms.
Group II: Posterior cingulate cortex (PCC)Experimental Treatment1 Intervention
PTSD participants will receive a neurofeedback signal reflecting PCC activity.
Group III: AmygdalaExperimental Treatment1 Intervention
PTSD participants will receive a neurofeedback signal reflecting amygdala activity.

MRI Biofeedback is already approved in United States for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as fMRI Neurofeedback for:
  • Post-traumatic Stress Disorder (PTSD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Andrew Nicholson

Lead Sponsor

Trials
1
Recruited
60+

McMaster University

Collaborator

Trials
936
Recruited
2,630,000+

Western University

Collaborator

Trials
31
Recruited
129,000+

University of Ottawa

Collaborator

Trials
231
Recruited
267,000+

Findings from Research

A new data-driven analysis method called intersubject covariance (ISC) was tested on data from 21 healthy individuals and 9 PTSD patients, revealing differences in brain activity regulation, particularly in the anterior cingulate cortex (ACC) and right inferior frontal gyrus (IFG).
ISC analysis showed that both groups developed individual strategies for self-regulating brain activity over time, suggesting that this method can provide deeper insights into the mechanisms of brain signal regulation compared to traditional general linear model (GLM) approaches.
Data-Driven Approach to the Analysis of Real-Time FMRI Neurofeedback Data: Disorder-Specific Brain Synchrony in PTSD.Zweerings, J., Sarasjรคrvi, K., Mathiak, KA., et al.[2021]
A novel neurofeedback intervention using real-time fMRI was tested on three combat veterans with chronic PTSD, and all participants tolerated the training well.
Two out of three participants experienced clinically meaningful improvements in their PTSD symptoms, along with changes in brain connectivity that aligned with these improvements, suggesting the potential efficacy of this approach.
Real-Time fMRI Neurofeedback with War Veterans with Chronic PTSD: A Feasibility Study.Gerin, MI., Fichtenholtz, H., Roy, A., et al.[2023]
A study involving 8 male combat Veterans with PTSD demonstrated that machine learning algorithms can accurately predict self-reported stress levels based on fMRI data collected during exposure to trauma-related virtual reality stimuli.
The developed framework for processing fMRI data could enhance real-time neurofeedback during virtual reality therapy, potentially improving treatment outcomes for Veterans with PTSD.
Framework for Accurate Classification of Self-Reported Stress From Multisession Functional MRI Data of Veterans With Posttraumatic Stress.Goel, R., Tse, T., Smith, LJ., et al.[2023]

References

Data-Driven Approach to the Analysis of Real-Time FMRI Neurofeedback Data: Disorder-Specific Brain Synchrony in PTSD. [2021]
Real-Time fMRI Neurofeedback with War Veterans with Chronic PTSD: A Feasibility Study. [2023]
Framework for Accurate Classification of Self-Reported Stress From Multisession Functional MRI Data of Veterans With Posttraumatic Stress. [2023]
The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: A meta-analysis of brain and behavioral outcomes. [2022]
Making sense of real-time functional magnetic resonance imaging (rtfMRI) and rtfMRI neurofeedback. [2018]
Quantification of adverse events associated with functional MRI scanning and with real-time fMRI-based training. [2021]
Neurofeedback training for alcohol dependence versus treatment as usual: study protocol for a randomized controlled trial. [2022]
Real-time fMRI neurofeedback training of the amygdala activity with simultaneous EEG in veterans with combat-related PTSD. [2021]
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