StressNCT01921088
Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
A study testing real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) and Ambulatory Training in people with Stress and Blood Pressure, run by University Hospital, Basel, Switzerland at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions. 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, Blood Pressure
- What is being tested?
- real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) and Ambulatory Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Jun 2019
- 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
- Access to smartphone
- Availability to participate in the study
Who cannot join
- Color blindness
- Presence of cardiovascular disease
- Medication intake affecting cardiovascular function
- Medical MRI contraindication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.
Read the detailed description
The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.
- Conditions
- Stress, Blood Pressure
- Being tested
- real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF), Ambulatory Training
- Keywords
- fMRI, Neurofeedback, Blood pressure, Psychophysiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)Other
Also called There are no specific branded names etc. associated with the intervention.
Subjects are provided with RT-fMRI-NF.
Ambulatory TrainingBehavioural
Subjects are provided with an ambulatory training.
| Study group | Role | What they receive |
|---|---|---|
| Contingent | Experimental | Contingent RT-fMRI-NF of brain activity in the target region of interest Receives: Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF); Behavioral: Ambulatory Training |
| Non-contingent | Sham comparator | Sham RT-fMRI-NF of brain activity of previously recorded subject Receives: Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF); Behavioral: Ambulatory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
assessed via oscillometry, expressed in mmHg
Measured: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
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: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Secondary outcomes (1)
Feedback on adverse events during the scanner and ambulatory training
number of subjects reporting an adverse event
Measured: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Swiss National Science Foundation, Korea University
- Responsible party
- Sponsor
- Investigators
- Marion Tegethoff, PhD, Principal investigator, University of BaselJong-Hwan Lee, PhD, Principal investigator, Korea UniversityGunther Meinlschmidt, PhD, Principal investigator, University of Basel;Ruhr-University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921088
- Sponsor's protocol ID
- NF1_137023_A
- Status last verified
- Jun 2019
- First submitted
- 2 Aug 2013
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Meinlschmidt G, Lee JH, Stalujanis E, Belardi A, Oh M, Jung EK, Kim HC, Alfano J, Yoo SS, Tegethoff M. Smartphone-Based Psychotherapeutic Micro-Interventions to Improve Mood in a Real-World Setting. Front Psychol. 2016 Jul 28;7:1112. doi: 10.3389/fpsyg.2016.01112. eCollection 2016.
PubMed 27516747
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions
- ClinicalTrials.gov ID
- NCT01921088
- Acronym / sponsor ID
- NF1_137023_A
- Conditions
- Stress, Blood Pressure
- Keywords
- fMRI, Neurofeedback, Blood pressure, Psychophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Swiss National Science Foundation, Korea University
- Study start
- Aug 2013
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 13 Aug 2013 (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 purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.
Detailed description
The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.
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: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF), Behavioral: Ambulatory TrainingContingent RT-fMRI-NF of brain activity in the target region of interest |
| Non-contingent | Sham comparator | Other: real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF), Behavioral: Ambulatory TrainingSham RT-fMRI-NF of brain activity of previously recorded subject |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sufficient spoken and written knowledge of English
- Right-handedness
- Access to smartphone
- Availability to participate in the study
Key exclusion criteria (4 listed)
- Color blindness
- Presence of cardiovascular disease
- Medication intake affecting cardiovascular function
- Medical MRI contraindication
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 |
|---|---|---|
| real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)Also: There are no specific branded names etc. associated with the intervention.Subjects are provided with RT-fMRI-NF. | Other | Contingent, Non-contingent |
| Ambulatory TrainingSubjects are provided with an ambulatory training. | Behavioural | Contingent, Non-contingent |
Primary outcome
Blood pressure
Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
assessed via oscillometry, expressed in mmHg
Blood oxygenation level dependent signal of the target brain region of interest
Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
blood oxygenation level dependent (BOLD) signal assessed via functional magnetic resonance imaging, expressed in relative BOLD signal intensity
1 secondary outcome
Feedback on adverse events during the scanner and ambulatory training
Time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Derived from this study: PubMed 27516747Meinlschmidt G, Lee JH, Stalujanis E, Belardi A, Oh M, Jung EK, Kim HC, Alfano J, Yoo SS, Tegethoff M. Smartphone-Based Psychotherapeutic Micro-Interventions to Improve Mood in a Real-World Setting. Front Psychol. 2016 Jul 28;7:1112. doi: 10.3389/fpsyg.2016.01112. eCollection 2016.
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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, PhD principal investigator
University of Basel
Jong-Hwan Lee, PhD principal investigator
Korea University
Gunther Meinlschmidt, PhD principal investigator
University of Basel;Ruhr-University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) and Ambulatory Training in people with Stress and Blood Pressure, run by University Hospital, Basel, Switzerland at 1 site in South Korea.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Blood pressure (time frame: study day 1; study day 2 (2 weeks later); anticipated: follow-up (up to 1 year)). 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?
On the ClinicalTrials.gov record for NCT01921088, which also lists 1 linked publication.
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 13 Jun 2019.