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

Not Applicable

Recruiting

• Conditions: Emotion Regulation; Healthy
• Interventions: Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2

• Registration Number: NCT06033053
• Lead Sponsor: University of Electronic Science and Technology of China

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-08-28
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2	The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear.
Experimental	Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2	The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear.

Primary Outcome Measures

Name	Time	Method
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.	40 minutes	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

Secondary Outcome Measures

Name	Time	Method
Level of behavioural arousal assessed on NRS from 0 to 10	10 minutes	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.

Trial Locations

Locations (1)

University of Electronic Science and Technology of China; 🇨🇳 Chengdu, Sichuan, China