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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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).
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome:

  • Hypothalamic-pituitary-adrenal (HPA) axis reactivity [ Time Frame: At study day one ]
    Assessed via salivary cortisol
  • Blood oxygenation level dependent signal of the target brain region of interest [ Time Frame: At study day one ]
    Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Psychophysiological stress reactivity - blood pressure [ Time Frame: At study day one ]
    Assessed via blood pressure
  • Psychophysiological stress reactivity - heart rate variability [ Time Frame: At study day one ]
    Assessed via heart rate variability
  • Psychophysiological stress reactivity - heart rate [ Time Frame: At study day one ]
    Assessed via heart rate
  • Subjective stress reactivity [ Time Frame: At study day one ]
    Assessed via Visual Analog Scale
  • Electrical activity of the brain [ Time Frame: At study day one ]
    Assessed via electroencephalography (EEG)


Original Secondary Outcome: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: August 10, 2015
Date Started: June 2017
Date Completion: January 2018
Last Updated: May 2, 2017
Last Verified: May 2017