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

Not Applicable

Withdrawn

• Conditions: Pituitary-Adrenal System; Stress
• Interventions: Other: Sham RT-fMRI-NF; Other: Contingent RT-fMRI-NF

• Registration Number: NCT02560233
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Study Timeline

• Study First Submitted: 2015-08-10
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Study Start: 2020-08
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-contingent	Sham RT-fMRI-NF	Sham RT-fMRI-NF
Contingent	Contingent RT-fMRI-NF	Contingent RT-fMRI-NF

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Korea University; 🇰🇷 Seoul, Korea, Republic of