MedDataX Logo

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

NCT ID: NCT02560233

Last Updated: 2024-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Pituitary-Adrenal System

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Basel

OTHER

Sponsor Role collaborator

Korea University

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marion Tegethoff, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Basel

Jong-Hwan Lee, Prof.

Role: PRINCIPAL_INVESTIGATOR

Korea University

Gunther Meinlschmidt, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Basel; Ruhr-University Bochum

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GRNP_2013S1A2A2035364_1

Identifier Type: -

Identifier Source: org_study_id