NCT01921088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 13, 2013

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

5.8 years

First QC Date

August 2, 2013

Last Update Submit

June 11, 2019

Conditions

StressBlood Pressure

Keywords

fMRINeurofeedbackBlood pressurePsychophysiology

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    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

    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 Outcomes (1)

  • Feedback on adverse events during the scanner and ambulatory training

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

Other Outcomes (3)

  • Psychobiological stress reactivity

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

  • Psychological stress reactivity

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

  • Functional connectivity

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

Study Arms (2)

Contingent

EXPERIMENTAL

Contingent RT-fMRI-NF of brain activity in the target region of interest

Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)Behavioral: Ambulatory Training

Non-contingent

SHAM COMPARATOR

Sham RT-fMRI-NF of brain activity of previously recorded subject

Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)Behavioral: Ambulatory Training

Interventions

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

Subjects are provided with RT-fMRI-NF.

Also known as: There are no specific branded names etc. associated with the intervention.
ContingentNon-contingent
Ambulatory TrainingBEHAVIORAL

Subjects are provided with an ambulatory training.

ContingentNon-contingent

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sufficient spoken and written knowledge of English
  • Right-handedness
  • Access to smartphone
  • Availability to participate in the study

You may not qualify if:

  • Color blindness
  • Presence of cardiovascular disease
  • Medication intake affecting cardiovascular function
  • Medical MRI contraindication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University

Seoul, 136-713, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 27516747DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 13, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

KR(1)