StressNCT02560233
Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
A study testing Contingent RT-fMRI-NF in people with Stress and Pituitary-Adrenal System, run by University Hospital, Basel, Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Pituitary-Adrenal System
- What is being tested?
- Contingent RT-fMRI-NF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sufficient spoken and written knowledge of English
- Right-handedness
- Ability to participate in study procedures
Who cannot join
- 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
About this study
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.
Read the 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).
- Conditions
- Stress, Pituitary-Adrenal System
- Being tested
- Contingent RT-fMRI-NF, Sham RT-fMRI-NF
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingent RT-fMRI-NFOther
Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.
Sham RT-fMRI-NFOther
Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.
| Study group | Role | What they receive |
|---|---|---|
| Contingent | Experimental | Contingent RT-fMRI-NF Receives: Other: Contingent RT-fMRI-NF |
| Non-contingent | Sham comparator | Sham RT-fMRI-NF Receives: Other: Sham RT-fMRI-NF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypothalamic-pituitary-adrenal (HPA) axis reactivity
Assessed via salivary cortisol
Measured: 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
Measured: At study day one
Secondary outcomes (5)
Psychophysiological stress reactivity - blood pressure
Assessed via blood pressure
Measured: At study day one
Psychophysiological stress reactivity - heart rate variability
Assessed via heart rate variability
Measured: At study day one
Psychophysiological stress reactivity - heart rate
Assessed via heart rate
Measured: At study day one
Subjective stress reactivity
Assessed via Visual Analog Scale
Measured: At study day one
Electrical activity of the brain
Assessed via electroencephalography (EEG)
Measured: At study day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startAug 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: No subjects were recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Korea University
- Responsible party
- Sponsor
- Investigators
- Marion Tegethoff, PD Dr., Principal investigator, University of BaselJong-Hwan Lee, Prof., Principal investigator, Korea UniversityGunther Meinlschmidt, Prof. Dr., Principal investigator, University of Basel; Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560233
- Sponsor's protocol ID
- GRNP_2013S1A2A2035364_1
- Status last verified
- Dec 2024
- First submitted
- 10 Aug 2015
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Stress-Reactivity by Real-Time Multimodal Functional Neuroimaging Based Neurofeedback
- ClinicalTrials.gov ID
- NCT02560233
- Acronym / sponsor ID
- GRNP_2013S1A2A2035364_1
- Conditions
- Stress, Pituitary-Adrenal System
- Keywords
- Neurofeedback, Stress, fMRI, Real-time fMRI Neurofeedback, Anterior cingulate cortex, Hypothalamic-pituitary-adrenal axis, Cortisol, EEG
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects were recruited
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Korea University
- Study start
- Aug 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contingent | Experimental | Other: Contingent RT-fMRI-NFContingent RT-fMRI-NF |
| Non-contingent | Sham comparator | Other: Sham RT-fMRI-NFSham RT-fMRI-NF |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sufficient spoken and written knowledge of English
- Right-handedness
- Ability to participate in study procedures
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingent RT-fMRI-NFSubjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest. | Other | Contingent |
| Sham RT-fMRI-NFSubjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject. | Other | Non-contingent |
Primary outcome
Hypothalamic-pituitary-adrenal (HPA) axis reactivity
Time frame: At study day one
Assessed via salivary cortisol
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
5 secondary outcomes
Psychophysiological stress reactivity - blood pressure
Time frame: At study day one
Psychophysiological stress reactivity - heart rate variability
Time frame: At study day one
Psychophysiological stress reactivity - heart rate
Time frame: At study day one
Subjective stress reactivity
Time frame: At study day one
Electrical activity of the brain
Time frame: At study day one
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marion Tegethoff, PD Dr. principal investigator
University of Basel
Jong-Hwan Lee, Prof. principal investigator
Korea University
Gunther Meinlschmidt, Prof. Dr. principal investigator
University of Basel; Ruhr-University Bochum
Questions about this trial
What is this clinical trial studying?
A study testing Contingent RT-fMRI-NF in people with Stress and Pituitary-Adrenal System, run by University Hospital, Basel, Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypothalamic-pituitary-adrenal (HPA) axis reactivity (time frame: At study day one). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.