Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions

Study Overview
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Brief Summary
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The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.

Detailed Description
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The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.

Official Title
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Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions

Conditions
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Stress, Blood Pressure

Intervention / Treatment
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* Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)
* Behavioral: Ambulatory Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient spoken and written knowledge of English Right-handedness Access to smartphone Availability to participate in the study Exclusion Criteria: Color blindness Presence of cardiovascular disease Medication intake affecting cardiovascular function 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 of brain activity in the target region of interest | Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)<br>* Subjects are provided with RT-fMRI-NF.<br>* Other names: There are no specific branded names etc. associated with the intervention.;Behavioral: Ambulatory Training<br>* Subjects are provided with an ambulatory training.<br>|
| Sham Comparator: Non-contingent<br>Sham RT-fMRI-NF of brain activity of previously recorded subject | Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)<br>* Subjects are provided with RT-fMRI-NF.<br>* Other names: There are no specific branded names etc. associated with the intervention.;Behavioral: Ambulatory Training<br>* Subjects are provided with an ambulatory training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | assessed via oscillometry, expressed in mmHg | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | 
| 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 | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feedback on adverse events during the scanner and ambulatory training | number of subjects reporting an adverse event | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fMRI, Neurofeedback, Blood pressure, Psychophysiology