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

June 11, 2019 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Contingent
Contingent RT-fMRI-NF of brain activity in the target region of interest
Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)
Subjects are provided with RT-fMRI-NF.
Other Names:
  • There are no specific branded names etc. associated with the intervention.
Behavioral: Ambulatory Training
Subjects are provided with an ambulatory training.
SHAM_COMPARATOR: Non-contingent
Sham RT-fMRI-NF of brain activity of previously recorded subject
Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)
Subjects are provided with RT-fMRI-NF.
Other Names:
  • There are no specific branded names etc. associated with the intervention.
Behavioral: Ambulatory Training
Subjects are provided with an ambulatory training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
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
study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
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
study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
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
study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation
Korea University
University of Basel

Investigators

  • Principal Investigator: Marion Tegethoff, PhD, University of Basel
  • Principal Investigator: Jong-Hwan Lee, PhD, Korea University
  • Principal Investigator: Gunther Meinlschmidt, PhD, University of Basel;Ruhr-University Bochum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (ESTIMATE)

August 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NF1_137023_A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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