Using brain imaging to help PTSD patients self-regulate their brain activity
Self-regulation of Post-traumatic Stress Disorder (PTSD) Neurocircuitry Using Multiple Sessions of Real-Time Functional Magnetic Resonance Imaging (RtfMRI)
This study is testing whether real-time brain imaging can help people with PTSD learn to control their brain activity and feel better over seven weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT05456958 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback in helping patients with post-traumatic stress disorder (PTSD) self-regulate abnormal brain activity associated with their condition. Participants will undergo clinical assessments and engage in multiple rt-fMRI neurofeedback sessions targeting specific brain regions, including the amygdala and posterior cingulate cortex. The study aims to compare the effects of these targeted neurofeedback sessions and monitor participants' biological rhythms and physical activity over a seven-week period. Data will be collected through self-report assessments and qualitative interviews to evaluate the impact of the intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have a primary diagnosis of PTSD and are comfortable using electronic devices.
Not a fit: Patients with serious medical conditions, neurological diseases, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide PTSD patients with a novel method to manage their symptoms by actively regulating their brain activity.
How similar studies have performed: Previous single-session studies have shown promise in using rt-fMRI neurofeedback for PTSD, but this multi-session approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-65 years old * Fluent English speaker * Comfortable using electronic devices (i.e., laptop, tablet, smartphone, etc.) * Meet criteria for a primary diagnosis of PTSD via the DSM-5 on the Clinician Administered PTSD Scale (CAPS-5). Note: given high rates of PTSD co-morbidity with major depressive disorder and anxiety disorders, these participants will not be excluded from the study, allowing for a naturalistic sample * Able to provide written informed consent. Exclusion Criteria: Medical * Pregnant women or women who are breastfeeding * Serious illness (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) that is not stabilized based on the judgment of primary investigator * Contraindications for research MRI, including metallic implants * Neurological disease, past head injury with loss of consciousness, stroke, seizures * Major untreated medical illness (e.g., cancer, thyroid disorder) * Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol. Psychological/Psychiatric * Active substance use or abuse as defined by the MINI or judged to be a problem by the PI * Current or past pain disorders, bipolar disorders or psychosis, schizophrenia, and any other psychotic disorder will be excluded * Participants will also be excluded for active suicidality, history of pervasive developmental disorders, or any other major medical illnesses * Meeting criteria for substance use disorder in the past three months on the MINI * Chronic opioid analgesic use within the last three months * Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol * Current engagement in a primary trauma-focused psychotherapy treatment. Other * History of claustrophobia * Previous engagement in biofeedback, neurofeedback, or any form of brain stimulation therapy.
Where this trial is running
London, Ontario
- Lawson Health Research Institute — London, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Andrew A Nicholson, PhD
- Email: dr.andrewnicholson@gmail.com
- Phone: 437-349-9324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.