Multi-session fMRI-Neurofeedback in PTSD
NCT05456958 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-10-09
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
Interventions
- OTHER
-
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.
- OTHER
-
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.
Sponsors & Collaborators
- collaborator OTHER
-
University of Ottawa
collaborator OTHER -
Western University
collaborator OTHER -
Andrew Nicholson
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-01
- Primary Completion
- 2025-09-30
- Completion
- 2025-09-30
Countries
- Canada
Study Locations
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