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Completed

NCT Number: NCT01921088

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

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.

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Key information

Conditions

Stress Blood Pressure

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Korea University

Seoul, 136-713, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)

Other

Subjects are provided with RT-fMRI-NF.

Other names: There are no specific branded names etc. associated with the intervention.

Ambulatory Training

Behavioral

Subjects are provided with an ambulatory training.

Primary outcomes

  1. Blood pressure

    Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

    assessed via oscillometry, expressed in mmHg

  2. Blood oxygenation level dependent signal of the target brain region of interest

    Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

    blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity

Secondary outcomes

  1. Feedback on adverse events during the scanner and ambulatory training

    Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

    number of subjects reporting an adverse event

Other outcomes

  1. Psychobiological stress reactivity

    Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

    assessed via heart rate, cortisol

  2. Psychological stress reactivity

    Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

    assessed via Multidimensional Mood State Questionnaire; Self-Assessment Manikin; Perceived Stress Scale

  3. Functional connectivity

    Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

    connectivity of brain activity determined by fmri signal

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Korea University
  • Swiss National Science Foundation
  • University of Basel

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2013
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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