fMRI-Neurofeedback for PTSD
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?
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Clinical Assessment
Baseline clinical assessments including MINI and CAPS-5 to establish mental health disorder diagnoses and PTSD symptom severity
Self-report Assessments
Participants complete a battery of self-report questionnaires via REDCap
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
Actigraphy Monitoring
Participants wear actigraphy devices to monitor biological rhythms and physical activity
Follow-up
Participants are monitored for changes in PTSD symptoms, interoceptive awareness, emotion regulation, and other measures at a 1-month follow-up
Treatment Details
Interventions
- MRI Biofeedback
- Sham-MRI Biofeedback
MRI Biofeedback is already approved in United States for the following indications:
- Post-traumatic Stress Disorder (PTSD)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Andrew Nicholson
Lead Sponsor
McMaster University
Collaborator
Western University
Collaborator
University of Ottawa
Collaborator