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Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback

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ClinicalTrials.gov Identifier: NCT02560233
Recruitment Status : Not yet recruiting
First Posted : September 25, 2015
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
University of Basel
Korea University
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The overall goal of the outlined study is to establish a Real-Time (RT) functional Magnetic Resonance Imaging (fMRI) Neurofeedback (NF) (RT-fMRI-NF) protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress.

Condition or disease Intervention/treatment Phase
Stress Pituitary-Adrenal System Other: Contingent RT-fMRI-NF Other: Sham RT-fMRI-NF Not Applicable

Detailed Description:
The overall goal of the outlined study is to establish an RT-fMRI-NF protocol aiming at modulating neural, endocrine, and subjective reactivity to psychosocial stress. More specifically, the investigators pursue the following goals: a) to evaluate whether neural and subjective stress-reactivity can be modified by training volitional control over targeted brain activity by means of RT-fMRI-NF; b) to evaluate whether neuromodulation by means of RT-fMRI-NF can be used as a new way to modulate hormone-release into the periphery; and c) to evaluate whether the efficacy of neuromodulation by RT-fMRI-NF can also be reflected on EEG data as well as the autonomic nervous system (ANS) measured by heart rate variability (HRV).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Contingent
Contingent RT-fMRI-NF
Other: Contingent RT-fMRI-NF
Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.

Sham Comparator: Non-contingent
Sham RT-fMRI-NF
Other: Sham RT-fMRI-NF
Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.




Primary Outcome Measures :
  1. Hypothalamic-pituitary-adrenal (HPA) axis reactivity [ Time Frame: At study day one ]
    Assessed via salivary cortisol

  2. Blood oxygenation level dependent signal of the target brain region of interest [ Time Frame: At study day one ]
    Blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity


Secondary Outcome Measures :
  1. Psychophysiological stress reactivity - blood pressure [ Time Frame: At study day one ]
    Assessed via blood pressure

  2. Psychophysiological stress reactivity - heart rate variability [ Time Frame: At study day one ]
    Assessed via heart rate variability

  3. Psychophysiological stress reactivity - heart rate [ Time Frame: At study day one ]
    Assessed via heart rate

  4. Subjective stress reactivity [ Time Frame: At study day one ]
    Assessed via Visual Analog Scale

  5. Electrical activity of the brain [ Time Frame: At study day one ]
    Assessed via electroencephalography (EEG)


Other Outcome Measures:
  1. Functional connectivity [ Time Frame: At study day one ]
    Connectivity of brain activity determined by fMRI signal

  2. Feedback on adverse events during the scanner training [ Time Frame: At study day one ]
    Number of subjects reporting an adverse event



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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
  • Ability to participate in study procedures

Exclusion Criteria:

  • Present or past psychological or psychiatric therapy
  • Major or unstable general medical conditions
  • Presence of cardiovascular disease
  • Current intake of any medication interfering hormonal assessments
  • History of major cerebral injury
  • 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): NCT02560233


Contacts
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Contact: Jong-Hwan Lee, Prof. +82-10-2733-3659 jhlee.jonghwanlee@gmail.com

Locations
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Korea, Republic of
Korea University Not yet recruiting
Seoul, Korea, Republic of, 136-713
Contact: Jong-Hwan Lee, Prof.       jhlee.jonghwanlee@gmail.com   
Principal Investigator: Jong-Hwan Lee, Prof.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
University of Basel
Korea University
Investigators
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Principal Investigator: Marion Tegethoff, PD Dr. University of Basel
Principal Investigator: Jong-Hwan Lee, Prof. Korea University
Principal Investigator: Gunther Meinlschmidt, Prof. Dr. University of Basel; Ruhr-University Bochum

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02560233     History of Changes
Other Study ID Numbers: GRNP_2013S1A2A2035364_1
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Hypothalamic-pituitary-adrenal axis
Neurofeedback
Stress
fMRI
Real-time fMRI Neurofeedback
Anterior cingulate cortex
Cortisol
EEG
Heart rate variability
Blood pressure
Simultaneous EEG/fMRI
Additional relevant MeSH terms:
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Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases