NCT03574974: PTSD

Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

Terminated NA Results posted Last updated 15 February 2024

What this trial tests

NA trial testing Experimental Feedback in Post-Traumatic Stress Disorder in 27 participants. Terminated before completion.

Timeline

1 June 2018

Primary endpoint
8 March 2022

8 March 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	27
Start date	1 June 2018
Primary completion	8 March 2022
Estimated completion	8 March 2022
Sites	2 locations across United States

Drugs / interventions tested

• Experimental Feedback
• Control Feedback

Conditions studied

• Post-Traumatic Stress Disorder — all drugs for Post-Traumatic Stress Disorder →

Sponsor

Yale University

Who can join

18 and older, any sex, with Post-Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Control Over the Amygdala Primary · baseline; 30 day-day follow up

Control over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless

Group	Value	95% CI
Experimental Feedback Intervention	-0.279	± 0.146
Control Feedback Intervention	0.202	± 0.167

Improvements in PTSD Symptoms Secondary · Baseline; 30-day follow-up

Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) \[CAPS-5\]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.

Group	Value	95% CI
Experimental Feedback Intervention	8.786	± 9.744
Control Feedback Intervention	10.545	± 13.441

Improvements in PTSD Symptoms Secondary · Baseline; 60-day follow-up

Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) \[CAPS-5\]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.

Group	Value	95% CI
Experimental Feedback Intervention	13.286	± 9.934
Control Feedback Intervention	9.364	± 13.246

Number of Participants With Changes in Resting State Connectivity to the Amygdala Secondary · Baseline; 60 days follow up.

The number of participants with a significant whole brain change in seed region connectivity to the amygdala from pre- to post-intervention will be assessed in the blood-oxygen-level dependent (BOLD) signal collected during resting state runs.

Group	Value	95% CI
Experimental Feedback Intervention	0
Control Feedback Intervention	0

Sponsor's own description

The primary purpose of this study is to investigate the efficacy of neurofeedback (NF) of real-time functional magnetic resonance imaging (rt-fMRI) data of the amygdala with regards to the reduction of post-traumatic stress disorder (PTSD) symptoms.

A secondary purpose of this study is to use fMRI as a method of investigating brain function in individuals with PTSD. This study approach provides a tool for probing the neurobiology of PTSD by (1) testing the critical role of the amygdala in this disorder, and by (2) examining how amygdala connectivity is related to both amygdala regulation and clinical symptoms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Amygdala downregulation training using fMRI neurofeedback in post-traumatic stress disorder: a randomized, double-blind trial.
   Zhao Z, Duek O, Seidemann R, Gordon C, et al · · 2023 · cited 22× · PMID 37230984 · DOI 10.1038/s41398-023-02467-6