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

NCT02560233 | Withdrawn

• 1 other identifier: GRNP_2013S1A2A2035364_1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Pituitary-Adrenal System

Keywords

Neurofeedback; Stress; fMRI; Real-time fMRI Neurofeedback; Anterior cingulate cortex; Hypothalamic-pituitary-adrenal axis; Cortisol; EEG; Heart rate variability; Blood pressure; Simultaneous EEG/fMRI

Outcome Measures

Primary Outcomes (2)

• Hypothalamic-pituitary-adrenal (HPA) axis reactivity

  Assessed via salivary cortisol

  At study day one

• 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

  At study day one

Secondary Outcomes (5)

• Psychophysiological stress reactivity - blood pressure

  At study day one

• Psychophysiological stress reactivity - heart rate variability

  At study day one

• Psychophysiological stress reactivity - heart rate

  At study day one

• Subjective stress reactivity

  At study day one

• Electrical activity of the brain

  At study day one

Other Outcomes (2)

• Functional connectivity

  At study day one

• Feedback on adverse events during the scanner training

  At study day one

Study Arms (2)

Contingent

EXPERIMENTAL

Contingent RT-fMRI-NF

Other: Contingent RT-fMRI-NF

Non-contingent

SHAM COMPARATOR

Sham RT-fMRI-NF

Other: Sham RT-fMRI-NF

Interventions

Contingent RT-fMRI-NF OTHER

Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.

Contingent

Sham RT-fMRI-NF OTHER

Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.

Non-contingent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sufficient spoken and written knowledge of English
• Right-handedness
• Ability to participate in study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Basel: collaborator
• Korea University: collaborator

Study Officials

• 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

  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 10, 2015
• First Posted: September 25, 2015
• Study Start: August 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share