Blood Pressure, Stress
Conditions
Keywords
fMRI, Neurofeedback, Blood pressure, Psychophysiology
Brief summary
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
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.
Interventions
OTHERreal-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)
Subjects are provided with RT-fMRI-NF.
BEHAVIORALAmbulatory Training
Subjects are provided with an ambulatory training.
Sponsors
University of Basel
Swiss National Science Foundation
Korea University
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | assessed via oscillometry, expressed in mmHg |
| Blood oxygenation level dependent signal of the target brain region of interest | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feedback on adverse events during the scanner and ambulatory training | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | number of subjects reporting an adverse event |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychobiological stress reactivity | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | assessed via heart rate, cortisol |
| Psychological stress reactivity | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | assessed via Multidimensional Mood State Questionnaire; Self-Assessment Manikin; Perceived Stress Scale |
| Functional connectivity | study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year) | connectivity of brain activity determined by fmri signal |
Countries
South Korea
Outcome results
None listed