Multi-session fMRI-Neurofeedback in PTSD

Launched by ANDREW NICHOLSON · Jul 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with Post-Traumatic Stress Disorder (PTSD) using a technique called real-time functional magnetic resonance imaging (rt-fMRI) neurofeedback. PTSD can cause significant distress and is linked to abnormal brain activity. This study aims to see if patients can learn to control these abnormal brain patterns over multiple sessions, which may help reduce their PTSD symptoms. Researchers will compare the effects of focusing on different brain areas related to PTSD to see which is more effective.

To participate, individuals need to be between 18 and 65 years old, speak English fluently, and be comfortable using electronic devices. They must also have a diagnosis of PTSD. However, people with certain medical conditions, active substance abuse, or specific psychiatric disorders will not be eligible. Participants can expect to take part in several sessions where they will receive neurofeedback while their brain activity is monitored. This study is currently recruiting participants, so if you or someone you know is interested, it might be a good opportunity to explore new treatment options for PTSD.

Gender

ALL

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.