Multi-session fMRI-Neurofeedback in PTSD
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Post Traumatic Stress Disorder
In brief
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.
Key facts
- Study ID
- NCT05456958
- Run by
- Andrew Nicholson
- People needed
- 60
- Starts
- 2023-05-01
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2024-10-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Lawson Health Research Institute — London, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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