Clinical trial NCT01921088: Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
Official title: Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Blood Pressure
Keywords: fMRI
Neurofeedback
Blood pressure
Psychophysiology
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Swiss National Science Foundation
name: Korea University
First posted: 2013-08-13
Enrollment: 31
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 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood pressure
timeFrame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
measure: Blood oxygenation level dependent signal of the target brain region of interest
timeFrame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Secondary outcomes:
measure: Feedback on adverse events during the scanner and ambulatory training
timeFrame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Other outcomes:
measure: Psychobiological stress reactivity
timeFrame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
measure: Psychological stress reactivity
timeFrame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
measure: Functional connectivity
timeFrame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University
Study officials:
affiliation: University of Basel
name: Marion Tegethoff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University
name: Jong-Hwan Lee, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Basel;Ruhr-University Bochum
name: Gunther Meinlschmidt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meinlschmidt G, Lee JH, Stalujanis E, Belardi A, Oh M, Jung EK, Kim HC, Alfano J, Yoo SS, Tegethoff M. Smartphone-Based Psychotherapeutic Micro-Interventions to Improve Mood in a Real-World Setting. Front Psychol. 2016 Jul 28;7:1112. doi: 10.3389/fpsyg.2016.01112. eCollection 2016.