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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06033053
• Other study ID #: BAM_lab_MOST_05
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: University of Electronic Science and Technology of China
• Contact: Benjamin Becker, Ph.D.
• Phone: +86-28-61830670
• Email: ben_becker[@]gmx.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Emotion Regulation
• Healthy

Intervention

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.

Locations

Country	Name	City	State
China	University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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