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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Stress, Pituitary-Adrenal System

Intervention / Treatment
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* Other: Contingent RT-fMRI-NF
* Other: Sham RT-fMRI-NF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EEG, Neurofeedback, Stress, fMRI, Real-time fMRI Neurofeedback, Anterior cingulate cortex, Hypothalamic-pituitary-adrenal axis, Cortisol, Heart rate variability, Blood pressure, Simultaneous EEG/fMRI