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

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ClinicalTrials.gov Identifier: NCT01921088
Recruitment Status : Active, not recruiting
First Posted : August 13, 2013
Last Update Posted : July 16, 2018
Sponsor:
Collaborators:
University of Basel
Swiss National Science Foundation
Korea University
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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

Condition or disease Intervention/treatment Phase
Stress Blood Pressure Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) Behavioral: Ambulatory Training Not Applicable

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  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
Study Start Date : August 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921088


Locations
Korea, Republic of
Korea University
Seoul, Korea, Republic of, 136-713
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Swiss National Science Foundation
Korea University
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01921088     History of Changes
Other Study ID Numbers: NF1_137023_A
First Posted: August 13, 2013    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Keywords provided by University Hospital, Basel, Switzerland:
fMRI
Neurofeedback
Blood pressure
Psychophysiology