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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02560233
Enrollment
0
Registered
2015-09-25
Start date
2020-08-31
Completion date
2020-12-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary-Adrenal System, Stress

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

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).

Interventions

Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.

Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Sponsors

University of Basel
CollaboratorOTHER
Korea University
CollaboratorOTHER
University Hospital, Basel, Switzerland
Lead SponsorOTHER

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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Blood oxygenation level dependent signal of the target brain region of interestAt study day oneBlood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity
Hypothalamic-pituitary-adrenal (HPA) axis reactivityAt study day oneAssessed via salivary cortisol

Secondary

MeasureTime frameDescription
Psychophysiological stress reactivity - heart rate variabilityAt study day oneAssessed via heart rate variability
Subjective stress reactivityAt study day oneAssessed via Visual Analog Scale
Electrical activity of the brainAt study day oneAssessed via electroencephalography (EEG)
Psychophysiological stress reactivity - heart rateAt study day oneAssessed via heart rate
Psychophysiological stress reactivity - blood pressureAt study day oneAssessed via blood pressure

Other

MeasureTime frameDescription
Functional connectivityAt study day oneConnectivity of brain activity determined by fMRI signal
Feedback on adverse events during the scanner trainingAt study day oneNumber of subjects reporting an adverse event

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026