Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback

The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress.

Study Overview

• Status: Unknown
• Conditions: Stress; Pituitary-Adrenal System
• Intervention / Treatment: Other: Contingent RT-fMRI-NF; Other: Sham RT-fMRI-NF

Detailed Description

The overall goal of the outlined study is to establish an RT-fMRI-NF protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress. More specifically, the investigators pursue the following goals: a) to evaluate whether neural and subjective stress-reactivity can be modified by training volitional control over targeted brain activity by means of RT-fMRI-NF; b) to evaluate whether neuromodulation by means of RT-fMRI-NF can be used as a new way to modulate hormone-release into the periphery; and c) to evaluate whether the efficacy of neuromodulation by RT-fMRI-NF can also be reflected on EEG data as well as the autonomic nervous system (ANS) measured by heart rate variability (HRV).

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-713
    • Korea University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Sufficient spoken and written knowledge of English
• Right-handedness
• Ability to participate in study procedures

Exclusion Criteria:

• Present or past psychological or psychiatric therapy
• Major or unstable general medical conditions
• Presence of cardiovascular disease
• Current intake of any medication interfering hormonal assessments
• History of major cerebral injury
• Medical MRI contraindication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingent; Contingent RT-fMRI-NF	Other: Contingent RT-fMRI-NF; Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.
Sham Comparator: Non-contingent; Sham RT-fMRI-NF	Other: Sham RT-fMRI-NF; Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypothalamic-pituitary-adrenal (HPA) axis reactivity	Assessed via salivary cortisol	At study day one
Blood oxygenation level dependent signal of the target brain region of interest	Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity	At study day one

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychophysiological stress reactivity - blood pressure	Assessed via blood pressure	At study day one
Psychophysiological stress reactivity - heart rate variability	Assessed via heart rate variability	At study day one
Psychophysiological stress reactivity - heart rate	Assessed via heart rate	At study day one
Subjective stress reactivity	Assessed via Visual Analog Scale	At study day one
Electrical activity of the brain	Assessed via electroencephalography (EEG)	At study day one

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional connectivity	Connectivity of brain activity determined by fMRI signal	At study day one
Feedback on adverse events during the scanner training	Number of subjects reporting an adverse event	At study day one

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Korea University; University of Basel
• Investigators: Principal Investigator: Marion Tegethoff, PD Dr., University of Basel; Principal Investigator: Jong-Hwan Lee, Prof., Korea University; Principal Investigator: Gunther Meinlschmidt, Prof. Dr., University of Basel; Ruhr-University Bochum

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 4, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Stress; fMRI; Cortisol; Blood pressure; EEG; Neurofeedback; Heart rate variability; Real-time fMRI Neurofeedback; Hypothalamic-pituitary-adrenal axis; Anterior cingulate cortex; Simultaneous EEG/fMRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases
• Other Study ID Numbers: GRNP_2013S1A2A2035364_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No