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

University of Electronic Science and Technology of China

Status: Enrolling

Conditions: Healthy; Emotion Regulation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06033053

BAM_lab_MOST_05

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

Experimental

Experimental group

Description:

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

Treatment:

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

Sham

Sham Comparator group

Description:

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

Treatment:

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