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

Sponsor

University of Electronic Science and Technology of China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033053

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Emotion Regulation Healthy	Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.Randomized active-sham group controlled between-subject: Group of healthy individuals will be randomly assigned to the experimental or the sham condition. The experimental group, will learn how to modulate the vmPFC-amygdala functional connectivity, while the sham group will try to modulate the functional connectivity of sham regions not involved in emotion regulation.

Masking:

Double (Participant, Investigator)

Masking Description:

The recruiter and the person in charge of conducting the experiment will be blind to the experimental condition, as will the participants.

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest. [40 min]
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

Level of behavioural arousal assessed on NRS from 0 to 10 [10 min]
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.

Other Outcome Measures

Level of behavioural anxiety assessed on NRS from 0 to 10 [10 min]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Electronic Science and Technology of China	Chengdu	Sichuan	China	611731

Sponsors and Collaborators

University of Electronic Science and Technology of China

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin Becker, Professor, University of Electronic Science and Technology of China

ClinicalTrials.gov Identifier:

NCT06033053

Other Study ID Numbers:

BAM_lab_MOST_05

First Posted:

Sep 13, 2023

Last Update Posted:

Sep 13, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 13, 2023