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
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
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
NCT ID
NCT02560233
First Posted
August 10, 2015
Last Updated
February 4, 2020
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University of Basel, Korea University
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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