Study protocol for a multi-session randomized sham-controlled trial of PCC- and amygdala-targeted neurofeedback for the treatment of PTSD
Bibliographic record
Abstract
BACKGROUND: Post-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. METHODS: This 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 REGISTRATION: This 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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.012 | 0.015 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.008 | 0.003 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.006 | 0.007 |
| Insufficient payload (model declined to judge) | 0.091 | 0.013 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".