Clinical trial NCT02560233: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Korea University
First posted: 2015-09-25
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Hypothalamic-pituitary-adrenal (HPA) axis reactivity
timeFrame: At study day one
measure: Blood oxygenation level dependent signal of the target brain region of interest
timeFrame: At study day one
Secondary outcomes:
measure: Psychophysiological stress reactivity - blood pressure
timeFrame: At study day one
measure: Psychophysiological stress reactivity - heart rate variability
timeFrame: At study day one
measure: Psychophysiological stress reactivity - heart rate
timeFrame: At study day one
measure: Subjective stress reactivity
timeFrame: At study day one
measure: Electrical activity of the brain
timeFrame: At study day one
Other outcomes:
measure: Functional connectivity
timeFrame: At study day one
measure: Feedback on adverse events during the scanner training
timeFrame: At study day one
Locations:
Study officials:
affiliation: University of Basel
name: Marion Tegethoff, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Jong-Hwan Lee, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel; Ruhr-University Bochum
name: Gunther Meinlschmidt, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: