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

NCT ID: NCT06033053

Last Updated: 2024-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-03-31

Brief Summary

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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

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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).

Conditions

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Emotion Regulation Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

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

Study Groups

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Experimental

The experimental group will learn how to modulate the vmPFC-amygdala functional connectivity while being presented with pictures inducing fear.

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Sham

The sham group will learn how to modulate the functional connectivity of sham ROIs while being presented with pictures inducing fear.

Group Type SHAM_COMPARATOR

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Electronic Science and Technology of China

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Becker

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin Becker, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Electronic Science and Technology of China

Locations

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University of Electronic Science and Technology of China

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Benjamin Becker, Ph.D.

Role: CONTACT

+86-28-61830670

Stefania Ferraro, Ph.D.

Role: CONTACT

+18684009672

Facility Contacts

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Stefania Ferraro, PhD

Role: primary

18684009672

Role: backup

Other Identifiers

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BAM_lab_MOST_05

Identifier Type: -

Identifier Source: org_study_id

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