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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Stress Pituitary-Adrenal System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Contingent

Contingent RT-fMRI-NF

Group Type EXPERIMENTAL

Contingent RT-fMRI-NF

Intervention Type OTHER

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

Non-contingent

Sham RT-fMRI-NF

Group Type SHAM_COMPARATOR

Sham RT-fMRI-NF

Intervention Type OTHER

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

Interventions

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Contingent RT-fMRI-NF

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

Intervention Type OTHER

Sham RT-fMRI-NF

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes