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

Primary Purpose

Stress, Pituitary-Adrenal System

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Contingent RT-fMRI-NF
Sham RT-fMRI-NF
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress focused on measuring Neurofeedback, Stress, fMRI, Real-time fMRI Neurofeedback, Anterior cingulate cortex, Hypothalamic-pituitary-adrenal axis, Cortisol, EEG, Heart rate variability, Blood pressure, Simultaneous EEG/fMRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Korea University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Contingent

Non-contingent

Arm Description

Contingent RT-fMRI-NF

Sham RT-fMRI-NF

Outcomes

Primary Outcome Measures

Hypothalamic-pituitary-adrenal (HPA) axis reactivity
Assessed via salivary cortisol
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

Secondary Outcome Measures

Psychophysiological stress reactivity - blood pressure
Assessed via blood pressure
Psychophysiological stress reactivity - heart rate variability
Assessed via heart rate variability
Psychophysiological stress reactivity - heart rate
Assessed via heart rate
Subjective stress reactivity
Assessed via Visual Analog Scale
Electrical activity of the brain
Assessed via electroencephalography (EEG)

Full Information

First Posted
August 10, 2015
Last Updated
February 4, 2020
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT02560233
Brief Title
Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
Official Title
Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Korea University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Pituitary-Adrenal System
Keywords
Neurofeedback, Stress, fMRI, Real-time fMRI Neurofeedback, Anterior cingulate cortex, Hypothalamic-pituitary-adrenal axis, Cortisol, EEG, Heart rate variability, Blood pressure, Simultaneous EEG/fMRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingent
Arm Type
Experimental
Arm Description
Contingent RT-fMRI-NF
Arm Title
Non-contingent
Arm Type
Sham Comparator
Arm Description
Sham RT-fMRI-NF
Intervention Type
Other
Intervention Name(s)
Contingent RT-fMRI-NF
Intervention Description
Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.
Intervention Type
Other
Intervention Name(s)
Sham RT-fMRI-NF
Intervention Description
Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.
Primary Outcome Measure Information:
Title
Hypothalamic-pituitary-adrenal (HPA) axis reactivity
Description
Assessed via salivary cortisol
Time Frame
At study day one
Title
Blood oxygenation level dependent signal of the target brain region of interest
Description
Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity
Time Frame
At study day one
Secondary Outcome Measure Information:
Title
Psychophysiological stress reactivity - blood pressure
Description
Assessed via blood pressure
Time Frame
At study day one
Title
Psychophysiological stress reactivity - heart rate variability
Description
Assessed via heart rate variability
Time Frame
At study day one
Title
Psychophysiological stress reactivity - heart rate
Description
Assessed via heart rate
Time Frame
At study day one
Title
Subjective stress reactivity
Description
Assessed via Visual Analog Scale
Time Frame
At study day one
Title
Electrical activity of the brain
Description
Assessed via electroencephalography (EEG)
Time Frame
At study day one
Other Pre-specified Outcome Measures:
Title
Functional connectivity
Description
Connectivity of brain activity determined by fMRI signal
Time Frame
At study day one
Title
Feedback on adverse events during the scanner training
Description
Number of subjects reporting an adverse event
Time Frame
At study day one

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Hwan Lee, Prof.
Phone
+82-10-2733-3659
Email
jhlee.jonghwanlee@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Tegethoff, PD Dr.
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong-Hwan Lee, Prof.
Organizational Affiliation
Korea University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gunther Meinlschmidt, Prof. Dr.
Organizational Affiliation
University of Basel; Ruhr-University Bochum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University
City
Seoul
ZIP/Postal Code
136-713
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Hwan Lee, Prof.
Email
jhlee.jonghwanlee@gmail.com
First Name & Middle Initial & Last Name & Degree
Jong-Hwan Lee, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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