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

Study Overview
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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).

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

Conditions
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Healthy, Emotion Regulation

Intervention / Treatment
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* Device: Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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<br>* The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.<br>|
| Sham Comparator: Sham<br>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<br>* The two groups will undergo the same paradigm while learning to modulate the vmPFC -amygdala pathway and the sham pathway.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 min |