Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions

Stress Clinical Trial

Official title:

Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01921088
• Other study ID #: NF1_137023_A
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: June 2019

Study information

• Verified date: June 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.

Description:

The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• 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

• Access to smartphone

• Availability to participate in the study

Exclusion Criteria:

• Color blindness

• Presence of cardiovascular disease

• Medication intake affecting cardiovascular function

• Medical MRI contraindication

Related Conditions & MeSH terms

• Blood Pressure
• Stress

Intervention

Other:
• real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)
Subjects are provided with RT-fMRI-NF.

Behavioral:
• Ambulatory Training
Subjects are provided with an ambulatory training.

Locations

Country	Name	City	State
Korea, Republic of	Korea University	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Korea University, Swiss National Science Foundation, University of Basel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychobiological stress reactivity	assessed via heart rate, cortisol	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Other	Psychological stress reactivity	assessed via Multidimensional Mood State Questionnaire; Self-Assessment Manikin; Perceived Stress Scale	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Other	Functional connectivity	connectivity of brain activity determined by fmri signal	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Primary	Blood pressure	assessed via oscillometry, expressed in mmHg	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
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	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Secondary	Feedback on adverse events during the scanner and ambulatory training	number of subjects reporting an adverse event	study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)