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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02560233
• Other study ID #: GRNP_2013S1A2A2035364_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: February 2020
• Source: University Hospital, Basel, Switzerland
• Contact: Jong-Hwan Lee, Prof.
• Phone: +82-10-2733-3659
• Email: jhlee.jonghwanlee[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pituitary Diseases
• Pituitary-Adrenal System
• Stress

Intervention

Other:
• Contingent RT-fMRI-NF
Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.
• Sham RT-fMRI-NF
Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Locations

Country	Name	City	State
Korea, Republic of	Korea University	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Korea University, University of Basel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Functional connectivity	Connectivity of brain activity determined by fMRI signal	At study day one
Other	Feedback on adverse events during the scanner training	Number of subjects reporting an adverse event	At study day one
Primary	Hypothalamic-pituitary-adrenal (HPA) axis reactivity	Assessed via salivary cortisol	At study day one
Primary	Blood oxygenation level dependent signal of the target brain region of interest	Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity	At study day one
Secondary	Psychophysiological stress reactivity - blood pressure	Assessed via blood pressure	At study day one
Secondary	Psychophysiological stress reactivity - heart rate variability	Assessed via heart rate variability	At study day one
Secondary	Psychophysiological stress reactivity - heart rate	Assessed via heart rate	At study day one
Secondary	Subjective stress reactivity	Assessed via Visual Analog Scale	At study day one
Secondary	Electrical activity of the brain	Assessed via electroencephalography (EEG)	At study day one