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Clinical Trials/NCT06033053
NCT06033053
Recruiting
Not Applicable

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

University of Electronic Science and Technology of China1 site in 1 country45 target enrollmentSeptember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotion Regulation
Sponsor
University of Electronic Science and Technology of China
Enrollment
45
Locations
1
Primary Endpoint
Functional connectivity computed from blood oxygenation level dependent (BOLD) functional magnetic resonance imaging between regions of interest.
Status
Recruiting
Last Updated
2 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
March 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Electronic Science and Technology of China
Responsible Party
Principal Investigator
Principal Investigator

Benjamin Becker

Professor

University of Electronic Science and Technology of China

Eligibility 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).

Outcomes

Primary Outcomes

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 Outcomes

  • Level of behavioural arousal assessed on NRS from 0 to 10(10 minutes)

Study Sites (1)

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