HealthyPredictorsNCT03297437
Predictors for Successful Neurofeedback Training
A study testing Neurofeedback training in people with Healthy, run by Frank Scharnowski at 1 site in Switzerland.
Trial summary
The primary objective of this study is to identify predictors of neurofeedback training success. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurofeedback training
- How many people
- 192 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 30 Sep 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 65 years. Magnetic resonance imaging compatibility.
Who cannot join
- Physical or psychiatric disorders (DSM-V diagnosis). Current substance abuse. Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Hospital of Psychiatry, University of Zurich
Zurich, Canton of Zurich, 8032
Frank Scharnowski, Prof. Dr., +41443842953, Frank.Scharnowski@uzh.ch
Ronald Sladky, PD Dr., +41443842667, ronald.sladky@uzh.ch
About this study
The primary objective of this study is to identify predictors of neurofeedback training success.
Read the detailed description
In the last decades, neurofeedback has been established as a promising scientific tool. Learning voluntary control over their own brain activity allows for establishing causal links between brain activity and mental functions. However, patients participants differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand why some participants are more successful in regulating their own brain activity than others. The objective of the present study is thus to identify predictors for successful learning self-regulation with real-time fMRI neurofeedback. To achieve this goal, we will evaluate the introspection ability of healthy participants using standardized psychological questionnaires and tasks. These scores will then be correlated with how well they learned self-regulation skills using established real-time fMRI neurofeedback protocols.
- Conditions
- Healthy
- Being tested
- Neurofeedback training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback trainingOther
In a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between introspection scores and learning success
The primary outcome measure is a correlation between introspection scores and neurofeedback learning success across all subjects.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frank Scharnowski
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank Scharnowski, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297437
- Sponsor's protocol ID
- PsychiatricUHZPUK
- Acronym
- Predictors
- Status last verified
- Sep 2017
- First submitted
- 26 Sep 2017
- Last updated
- 2 Oct 2017
- 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 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors for Successful Neurofeedback Training
- ClinicalTrials.gov ID
- NCT03297437
- Acronym / sponsor ID
- Predictors / PsychiatricUHZPUK
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Frank ScharnowskiUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 29 Sep 2017 (actual)
- 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 primary objective of this study is to identify predictors of neurofeedback training success.
Detailed description
In the last decades, neurofeedback has been established as a promising scientific tool. Learning voluntary control over their own brain activity allows for establishing causal links between brain activity and mental functions. However, patients participants differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand why some participants are more successful in regulating their own brain activity than others. The objective of the present study is thus to identify predictors for successful learning self-regulation with real-time fMRI neurofeedback. To achieve this goal, we will evaluate the introspection ability of healthy participants using standardized psychological questionnaires and tasks. These scores will then be correlated with how well they learned self-regulation skills using established real-time fMRI neurofeedback protocols.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 - 65 years. Magnetic resonance imaging compatibility.
Key exclusion criteria (1 listed)
- Physical or psychiatric disorders (DSM-V diagnosis). Current substance abuse. Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).
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 |
|---|---|---|
| Neurofeedback trainingIn a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject. | Other | – |
Primary outcome
correlation between introspection scores and learning success
Time frame: 48 months
The primary outcome measure is a correlation between introspection scores and neurofeedback learning success across all subjects.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback training in people with Healthy, run by Frank Scharnowski at 1 site in 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Oct 2017. 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 Switzerland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Scharnowski, Prof. Dr. (+41443842953, Frank.Scharnowski@uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between introspection scores and learning success (time frame: 48 months). 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 2 Oct 2017.