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

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ClinicalTrials.gov Identifier: NCT06033053
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : April 11, 2024
Sponsor:
Information provided by (Responsible Party):
Benjamin Becker, University of Electronic Science and Technology of China

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : March 31, 2025
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest. [ Time Frame: 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 :
  1. Level of behavioural arousal assessed on NRS from 0 to 10 [ Time Frame: 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.


Other Outcome Measures:
  1. Level of behavioural anxiety assessed on NRS from 0 to 10 [ Time Frame: 10 minutes ]
    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
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06033053


Contacts
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Contact: Benjamin Becker, Ph.D. +86-28-61830670 ben_becker@gmx.de
Contact: Stefania Ferraro, Ph.D. +18684009672 stefania@uestc.edu.cn

Locations
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China, Sichuan
University of Electronic Science and Technology of China Recruiting
Chengdu, Sichuan, China, 611731
Contact: Stefania Ferraro, PhD    18684009672    stefania@uestc.edu.cn   
Contact       stefania@uestc.edu.cn   
Sponsors and Collaborators
University of Electronic Science and Technology of China
Investigators
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Principal Investigator: Benjamin Becker, Ph.D. University of Electronic Science and Technology of China
More Information
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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: September 13, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No