Evidence map›Paper›PMID 40665286›Full record

ArticleBMC psychiatry2025

Study protocol for a multi-session randomized sham-controlled trial of PCC- and amygdala-targeted neurofeedback for the treatment of PTSD.

Jonathan M Lieberman, Ruth A Lanius, Jean Théberge, Benicio N Frey, Paul A Frewen, Frank Scharnowski, David Steyrl, Tomas Ros, Maria Densmore, Emma Tassinari and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC psychiatry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05456958 (Self-regulation of Post-traumatic Stress Disorder), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05456958 narecruitingnot on this map

Self-regulation of Post-traumatic Stress Disorder (PTSD) Neurocircuitry Using Multiple Sessions of Real-Time Functional Magnetic Resonance Imaging (RtfMRI)

TypeinterventionalSponsorAndrew NicholsonRan2023 to 2025Enrolled60ConditionsPost Traumatic Stress DisorderArmsMRI Biofeedback, Sham-MRI Biofeedback
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Jonathan M LiebermanDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada. liebermj@mcmaster.ca.
Ruth A LaniusDepartment of Psychiatry, Western University, London, ON, Canada.
Jean ThébergeImaging, Lawson Research Institute, London, ON, Canada.
Benicio N FreyDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.
Paul A FrewenDepartment of Neuroscience, Western University, London, ON, Canada.
Frank ScharnowskiDepartment of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.
David SteyrlDepartment of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.
Tomas RosDepartment of Neuroscience and Psychiatry, University of Geneva, Geneva, Switzerland.
Maria DensmoreImaging, Lawson Research Institute, London, ON, Canada.
Emma TassinariGraduate Program in Neuroscience, Faculty of Health Sciences, Western University, London, ON, Canada.
Vangel MaticSchool of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
Niki Hosseini-KamkarDepartment of Liberal Arts, Rochester Institute of Technology, Dubai Silicon Oasis, Dubai, United Arab Emirates.
Sandhya NarikuzhyDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada.
Fardous HosseinyAtlas Institute for Veterans and Families, Ottawa, ON, Canada.
Rakesh JetlyThe Institute of Mental Health Research, University of Ottawa, Royal Ottawa Hospital, Ottawa, ON, Canada.
Andrew A NicholsonDepartment of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, ON, Canada. andrew.nicholson@theroyal.ca.

Funding

Banting Research Foundation 2021-1424CIHR 187470CIHR 483268Marie Sklodowska-Curie Individual Fellowship 897709
6 · The paper itself

Abstract

backgroundPost-traumatic stress disorder (PTSD) is marked by distressing and often chronic symptoms, including the reliving and re-experiencing of trauma memories, avoidance, negative alterations in cognition and mood, heightened arousal and reactivity, and dissociation. Current psychotherapies and pharmacotherapies may yield suboptimal results for many individuals with PTSD, underscoring the need for new approaches. Recent neuroimaging research highlights functional disruptions in brainstem, cerebellar, limbic, and cortical networks underlying PTSD. Real-time functional magnetic resonance imaging neurofeedback (rt-fMRI-NFB) is an emerging intervention that has directly targeted limbic (i.e., the amygdala) and cortical (i.e., the posterior cingulate [PCC]) regions and has shown promising initial findings in PTSD. However, key research gaps remain, such as the need for rigorous randomized controlled trials (RCTs) to establish clinical efficacy and neurophysiological specificity, determine optimal brain targets, and evaluate dose-response relationships.

methodsThis double-blind, multi-session RCT investigates whether targeting distinct brain regions via rt-fMRI-NFB yields differential therapeutic effects in individuals with PTSD (n = 72). Participants will be randomly assigned to PCC-targeted rt-fMRI-NFB, amygdala-targeted rt-fMRI-NFB, or a sham-control group. Each participant will complete three rt-fMRI-NFB sessions over three weeks, with clinical assessments at baseline, after each session, and at a one-month follow-up. The sham group will receive a 'yoked' feedback signal from a random participant in one of the experimental groups. The primary outcome is PTSD symptom severity, measured using the PTSD Checklist for DSM-5 (PCL-5). Secondary outcomes include depressive symptoms, emotion regulation difficulties, dissociation, anxiety, interoceptive awareness, sleep quality, and state PTSD symptoms during trauma provocation. Neural outcomes will also be examined, focusing on brain activation and connectivity patterns. Additionally, qualitative interviews and actigraphy will assess participants' subjective experiences and track sleep and physical activity patterns. DISCUSSION: This trial aims to address critical research gaps by evaluating the therapeutic potential of rt-fMRI-NFB targeting the PCC and amygdala in PTSD. By employing a wide range of data collection methods, this study will provide valuable insights into the clinical and neural effects of rt-fMRI-NFB. This study will be the first to investigate the phenomenological dimension and physiological impacts of rt-fMRI-NFB in this population. Taken together, these findings are expected to contribute to the development of targeted neurofeedback interventions and clarify the therapeutic mechanisms underlying rt-fMRI-NFB for PTSD.

trial registrationThis study has been registered with ClinicalTrials.gov under the trial registration number NCT05456958. It was initially registered on July 13th, 2022, and most recently updated on October 9th, 2024.

Indexed as

AmygdalaGyrus CinguliNeurofeedbackStress Disorders, Post-TraumaticAdultDouble-Blind MethodFemaleHumansMagnetic Resonance ImagingMaleMiddle AgedRandomized Controlled Trials as TopicTreatment OutcomeAmygdalaPosterior cingulate cortexPost-traumatic stress disorderRandomized controlled trialReal-time fMRI neurofeedback

Identifiers

PMID40665286
PMCPMC12265235

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.