NCT05456958 Multi-session fMRI-Neurofeedback in PTSD
| NCT ID | NCT05456958 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Andrew Nicholson |
| Condition | Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-05-01 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05456958 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05456958 currently recruiting?
Yes, NCT05456958 is actively recruiting participants. Contact the research team at dr.andrewnicholson@gmail.com for enrollment information.
Where is the NCT05456958 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT05456958 clinical trial?
NCT05456958 is sponsored by Andrew Nicholson. The trial plans to enroll 60 participants.