Recruiting

fMRI-Neurofeedback

Sponsor:

Andrew Nicholson

Code:

NCT05456958

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

MRI Biofeedback

Sham-MRI Biofeedback

Study Details

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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT05456958

Start date

May 1, 2023

Status verified date

Oct, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amygdala

PTSD participants will receive a neurofeedback signal reflecting amygdala activity.

experimental: Posterior cingulate cortex (PCC)

PTSD participants will receive a neurofeedback signal reflecting PCC activity.

experimental: Sham-control

PTSD participants will receive a sham neurofeedback signal, i.e., from a successful participant in one of the experimental arms.

Interventions

MRI Biofeedback

We will use state-of-the-art fMRI and neurofeedback of brain signals in order to teach patients with PTSD to self-regulate pathological brain activity that is associated with their symptoms. Indeed, feedback information is crucial for learning, where rt-fMRI-based neurofeedback makes information about brain activity accessible to our consciousness (Ros et al., 2014; Sitaram et al., 2017). It thus provides a reinforcement signal to induce personalized learning mechanisms, allowing individuals to search for appropriate cognitive strategies to voluntarily control brain activity. The feedback signal will come from activity within either the amygdala or PCC.

Sham-MRI Biofeedback

In the sham-control arm (N=20), individuals will receive fake neurofeedback signal, i.e., from a successful participant in one of the experimental arms.

Primary outcome measure

  • Changes in PTSD symptoms over neurofeedback training sessions [ Time Frame: Change in baseline (pre-neurofeedback) at 1-week intervals (i.e., post-neurofeedback session 1, 2, 3) and at a 1-month follow-up) ]
  • Region-of-interest (ROI) downregulation analysis over neurofeedback training sessions [ Time Frame: Change in ROI activation between neurofeedback sessions 1, 2, and 3 ]

Central Contacts and Locations

Central contacts

Andrew A Nicholson, PhD

437-349-9324dr.andrewnicholson@gmail.com

Jonathan M Lieberman, BSc

647-501-0510liebermj@mcmaster.ca

Locations

Lawson Health Research Institute

Recruiting

London, Ontario, Canada, N6C 2R5

Contacts

David Hill

519-667-6649david.hill@lawsonresearch.com

More Information

Sponsor

Andrew Nicholson

Last update posted

Oct 9, 2024

Last verified

Oct, 2024

Keywords

  • Real-time neurofeedback
  • Functional magnetic resonance imaging (fMRI)
  • Post-traumatic stress disorder (PTSD)
  • Posterior cingulate cortex (PCC)
  • Amygdala

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Nicholson on 2024-10-09.