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

NCT06033053 | Recruiting

• 1 other identifier: BAM_lab_MOST_05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotion Regulation; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Level of behavioural arousal assessed on NRS from 0 to 10

  10 minutes

Other Outcomes (1)

• Level of behavioural anxiety assessed on NRS from 0 to 10

  10 minutes

Study Arms (2)

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

Sham

SHAM COMPARATOR

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

Interventions

Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2 DEVICE

The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.

Experimental; Sham

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 611731, China

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Benjamin Becker, Ph.D.

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin Becker, Ph.D.

CONTACT

+86-28-61830670; ben_becker@gmx.de

Stefania Ferraro, Ph.D.

CONTACT

+18684009672; stefania@uestc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The recruiter and the person in charge of conducting the experiment will be blind to the experimental condition, as will the participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)