Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05456958

Multi-session fMRI-Neurofeedback in PTSD

Led by Andrew Nicholson · Updated on 2024-10-09

60

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

A

Andrew Nicholson

Lead Sponsor

M

McMaster University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Multi-session fMRI-Neurofeedback in PTSD

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Fluent in English
  • Comfortable using electronic devices such as a laptop, tablet, or smartphone
  • Meet criteria for a primary diagnosis of PTSD based on the Clinician Administered PTSD Scale (CAPS-5)
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Serious unstable illnesses including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic diseases
  • Contraindications for MRI such as metallic implants
  • Neurological diseases, past head injury with loss of consciousness, stroke, or seizures
  • Major untreated medical illnesses like cancer or thyroid disorders
  • Any condition affecting capacity to give informed consent or adhere to the study
  • Active substance use or abuse or substance use disorder in the past three months
  • Current or past bipolar disorder, psychosis, schizophrenia, or other psychotic disorders
  • Active suicidality or history of pervasive developmental disorders
  • Chronic opioid use within the last three months
  • Current participation in trauma-focused psychotherapy
  • History of claustrophobia
  • Previous participation in biofeedback, neurofeedback, or brain stimulation therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lawson Health Research Institute

London, Ontario, Canada, N6C 2R5

Actively Recruiting

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Research Team

A

Andrew A Nicholson, PhD

CONTACT

J

Jonathan M Lieberman, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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