Real-time Neurofeedback Training of Fronto-limbic Regions Functional Connectivity

Real-time Neurofeedback Training of Fronto-limbic Areas Functional Connectivity to Reduce Arousal

This is randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aimed at modulating the ventromedial prefrontal cortex (vmPFC)-amygdala pathway to control subjective anxiety and arousal.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Emotion Regulation
• Intervention / Treatment: Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2

Detailed Description

The present randomized active-sham group controlled between-subject real-time fMRI neurofeedback trial aims at determining if (1) subjects can gain volitional control over the vmPFC-amygdala pathway involved in implicit emotion regulation and arousal by means of connectivity informed neurofeedback, (2) whether the training has specific effects on the behavioral and psychophysiological arousal level, and (3) or the amygdala or the vmPFC connectivity, respectively.

The present project will determine the efficacy of the modulation of the vmPFC-amygdala functional connectivity pathway using vmPFC-amygdala upregulation (n = 25 subjects) compared to a sham control condition (targeting pathways not involved in emotion regulation, n = 20).

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Benjamin Becker, Ph.D.; Phone Number: +86-28-61830670; Email: ben_becker@gmx.de
• Study Contact Backup: Name: Stefania Ferraro, Ph.D.; Phone Number: +18684009672; Email: stefania@uestc.edu.cn

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 611731
      • Recruiting
      • University of Electronic Science and Technology of China
      • Contact: Stefania Ferraro, PhD; Phone Number: 18684009672; Email: stefania@uestc.edu.cn
      • Contact: Email: stefania@uestc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• age > 18 years old
• other genders
• No past or current psychiatric or neurological or other main disorders.

Exclusion Criteria:

• Pregnant, taking oral contraceptives
• Current use of medications
• Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear.	Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2; The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.
Sham Comparator: Sham; The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear.	Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2; The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.	Increased functional connectivity computed from BOLD fMRI over the course of the real-time NF-fMRI training sessions in the neurofeedback group (regions of interest: bilateral amygdala and prefrontal area) but not in the sham group (regions of interest: bilateral motor cortex and primary auditory areas). Functional connectivity strength will be represented by bivariate regression coefficients from a general linear model characterizing the association between their BOLD signal timeseries	40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of behavioural arousal assessed on NRS from 0 to 10	After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of arousal on a Numeric Rating Scale (NRS) from 0 (lowest level of arousal) to 10 (highest level of arousal). The neurofeedback group will present lower level of arousal in comparison to the sham group.	10 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of behavioural anxiety assessed on NRS from 0 to 10	After the presentation of movie clips inducing strong fearful emotions, the participant will rate the behavioural level of anxiety on a Numeric Rating Scale (NRS) from 0 (lowest level of anxiety) to 10 (highest level of anxiety). The neurofeedback group will present lower level of anxiety in comparison to the sham group.	10 minutes

Collaborators and Investigators

• Sponsor: University of Electronic Science and Technology of China
• Investigators: Principal Investigator: Benjamin Becker, Ph.D., University of Electronic Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BAM_lab_MOST_05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No