NeurofeedbackNCT05711550
Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome
A study testing Real Neurofeedback in people with Neurofeedback, run by Philipp Stämpfli at 1 site in Switzerland.
Trial summary
In this basic research project a novel form of neurofeedback is investigated, in which in addition to the use of 1) normal frequency bands (1-35 Hertz), 2) very slow signals (low frequency; < 0.1 Hertz) are used, which correspond more to the basic excitability of the brain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurofeedback
- What is being tested?
- Real Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Jan 2023to 18 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy
- Written informed consent after participants' information
- Fluent in German language (required for an adequate answering of the questionnaires)
- No previous experience with neurofeedback treatments
Who cannot join
- Alcohol, drug and analgesics consumption within the last 24 hours
- Pre-existing neurological and/or psychiatric conditions
- History of brain injuries
- Alcohol and drug abuse
- Chronic diseases that require permanent medication
- Exclusion criteria met based on the screening questionnaire
Show all 9Show fewer
- General contraindications for MR-testings (e.g. claustrophobia, pace maker, cochlear implant, insulin pump)
- Hypersensitivity to loud noises
- Incapable of lying still during a longer period of time
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric University Hospital Zurich
Zurich, Canton of Zurich, 8032
About this study
In this basic research project a novel form of neurofeedback is investigated, in which in addition to the use of 1) normal frequency bands (1-35 Hertz), 2) very slow signals (low frequency; < 0.1 Hertz) are used, which correspond more to the basic excitability of the brain. Because of the slow signal characteristics, this method is called infra-low frequency neurofeedback (ILF-NFB for short). Although this method has been successfully applied in clinical settings since the 1980s, the mechanisms underlying the effect are largely unexplored. For that purpose, a project consistiong of three studies will be conducted in order to investigate the neurophysiological effects of both signal elements on healthy participants:
- Study 1 examines the effects of normal frequency band training alone.
- Study 2 examines the effects of low frequency training.
- Study 3 examines the effects of the combination of normal frequency band and low frequency training
Read more
For each study, a total of 40 clean data sets are to be collected, resulting in a minimum amount of 120 participants for all three studies.
All three studies investigate the effects of the neurofeedback on brain connectivity patterns by means of functional magnetic resonance imaging (fMRI), accompanied by measurements of the autonomic nervous system (ANS) and behavior.
- Conditions
- Neurofeedback
- Being tested
- Real Neurofeedback, Sham Neurofeedback
- Keywords
- Neurofeedback, fMRI, resting-state
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real NeurofeedbackDevice
Real Neurofeedback with visual and acoustic feedback presentation based on the EEG-signal from the participant (Signals used described in corresponding study arm). The NFB-signals are obtained from the T4 and P4 positions according to the 10-20 EEG placement consensus. NFB is done using the software package Cygnet (BEE Medic GmbH Technologies, Kirchberg, Switzerland) and for all participants the same neurofeedback-animation is used. NFB training duration is approx. 30min
Sham NeurofeedbackDevice
The sham neurofeedback is performed in identical fashion using the same software, feedback, electrode placement, duration as in the real neurofeedback. Only difference is that a pre-recorded EEG-dataset will be used and the feedback signal is thus independent from the brain activity of the participant.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects: Study 1 | Experimental | This arm corresponds to study 1 (Real Neurofeedback uses only normal frequency band signals ranging from 1 to 35 Hz from the EEG-signal). All included participants participate at 2 experimental conditions (Real Neurofeedback, Sham Neurofeedback) at 2 different days in a randomized order. Both, the investigators and the participants are blinded in regard to the intervention they receive at the two experimental visits. Receives: Device: Real Neurofeedback; Device: Sham Neurofeedback |
| Healthy Subjects: Study 2 | Experimental | This arm corresponds to study 2 (Real Neurofeedback uses only infra-low frequencies below 0.1Hz from the EEG-signal). All included participants participate at 2 experimental conditions (Real Neurofeedback, Sham Neurofeedback) at 2 different days in a randomized order. Both, the investigators and the participants are blinded in regard to the intervention they receive at the two experimental visits. Receives: Device: Real Neurofeedback; Device: Sham Neurofeedback |
| Healthy Subjects: Study 3 | Experimental | This arm corresponds to study 3 (normal frequency band \& infra-low frequencies are used in Real Neurofeedback). All included participants participate at 2 experimental conditions (Real Neurofeedback, Sham Neurofeedback) at 2 different days in a randomized order. Both, the investigators and the participants are blinded in regard to the intervention they receive at the two experimental visits. Receives: Device: Real Neurofeedback; Device: Sham Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain connectivity
Comparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)
Measured: 90 Minutes
Secondary outcomes (7)
Heart rate Variability Pre/Post Interventions
Comparison of the Pre-Post intervention differences in heart rate variability (during fMRI measurements)
Measured: 90 Minutes
Respiration frequency Pre/Post Interventions
Comparison of the Pre-Post intervention differences in respiration frequency (during fMRI measurements)
Measured: 90 Minutes
Heart rate variability during interventions
Comparison of heart rate variability measured during both interventions (Neurofeedback and Sham Neurofeedback)
Measured: 30 Minutes
Respiration frequency during interventions
Comparison of respirateion frequency measured during both interventions (Neurofeedback and Sham Neurofeedback)
Measured: 30 Minutes
Electrodermal activity during interventions
Comparison of electrodermal activity (skin conductance) measured during both interventions (Neurofeedback and Sham Neurofeedback)
Measured: 30 Minutes
Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions
Comparison of power spectral density (PSD) of the delta, theta, alpha, beta and gamma frequency bands recorded by the neurofeedback equipment during both interventions (Neurofeedback and Sham Neurofeedback)
Measured: 30 Minutes
Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions
Comparison of power spectral density (PSD) of low-frequency components (< 0.1Hz) recorded by the neurofeedback equipment during both interventions (Neurofeedback and Sham Neurofeedback)
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start13 Jan 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
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 NeurofeedbackStudies 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, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipp Stämpfli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philipp Stämpfli, Psychiatric University Hospital, Zurich
- Investigators
- Philipp Stämpfli, PD PhD, Principal investigator, Psychiatric University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711550
- Sponsor's protocol ID
- ILF_NFB_Allstudies
- Status last verified
- Feb 2025
- First submitted
- 13 Jan 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Matos NMP, Stampfli P, Seifritz E, Brugger M. Disassembling infra-low-frequency neurofeedback: A neurophysiological investigation of its feedback components. Neuroimage. 2026 Jan;325:121647. doi: 10.1016/j.neuroimage.2025.121647. Epub 2025 Dec 12.
PubMed 41391628
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome
- ClinicalTrials.gov ID
- NCT05711550
- Acronym / sponsor ID
- ILF_NFB_Allstudies
- Conditions
- Neurofeedback
- Keywords
- Neurofeedback, fMRI, resting-state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Philipp StämpfliUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 3 Feb 2023 (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.
In this basic research project a novel form of neurofeedback is investigated, in which in addition to the use of 1) normal frequency bands (1-35 Hertz), 2) very slow signals (low frequency; < 0.1 Hertz) are used, which correspond more to the basic excitability of the brain. Because of the slow signal characteristics, this method is called infra-low frequency neurofeedback (ILF-NFB for short). Although this method has been successfully applied in clinical settings since the 1980s, the mechanisms underlying the effect are largely unexplored. For that purpose, a project consistiong of three studies will be conducted in order to investigate the neurophysiological effects of both signal elements on healthy participants:
- Study 1 examines the effects of normal frequency band training alone.
- Study 2 examines the effects of low frequency training.
- Study 3 examines the effects of the combination of normal frequency band and low frequency training
For each study, a total of 40 clean data sets are to be collected, resulting in a minimum amount of 120 participants for all three studies.
All three studies investigate the effects of the neurofeedback on brain connectivity patterns by means of functional magnetic resonance imaging (fMRI), accompanied by measurements of the autonomic nervous system (ANS) and behavior.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects: Study 1 | Experimental | Device: Real Neurofeedback, Device: Sham NeurofeedbackThis arm corresponds to study 1 (Real Neurofeedback uses only normal frequency band signals ranging from 1 to 35 Hz from the EEG-signal). All included participants participate at 2 experimental conditions (Real Neurofeedback, Sham Neurofeedback) at 2 different days in a randomized order. Both, the investigators and the participants are blinded in regard to the intervention they receive at the two experimental visits. |
| Healthy Subjects: Study 2 | Experimental | Device: Real Neurofeedback, Device: Sham NeurofeedbackThis arm corresponds to study 2 (Real Neurofeedback uses only infra-low frequencies below 0.1Hz from the EEG-signal). All included participants participate at 2 experimental conditions (Real Neurofeedback, Sham Neurofeedback) at 2 different days in a randomized order. Both, the investigators and the participants are blinded in regard to the intervention they receive at the two experimental visits. |
| Healthy Subjects: Study 3 | Experimental | Device: Real Neurofeedback, Device: Sham NeurofeedbackThis arm corresponds to study 3 (normal frequency band \& infra-low frequencies are used in Real Neurofeedback). All included participants participate at 2 experimental conditions (Real Neurofeedback, Sham Neurofeedback) at 2 different days in a randomized order. Both, the investigators and the participants are blinded in regard to the intervention they receive at the two experimental visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy
- Written informed consent after participants' information
- Fluent in German language (required for an adequate answering of the questionnaires)
- No previous experience with neurofeedback treatments
Key exclusion criteria (9 listed)
- Alcohol, drug and analgesics consumption within the last 24 hours
- Pre-existing neurological and/or psychiatric conditions
- History of brain injuries
- Alcohol and drug abuse
- Chronic diseases that require permanent medication
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 NeurofeedbackReal Neurofeedback with visual and acoustic feedback presentation based on the EEG-signal from the participant (Signals used described in corresponding study arm). The NFB-signals are obtained from the T4 and P4 positions according to the 10-20 EEG placement consensus. NFB is done using the software package Cygnet (BEE Medic GmbH Technologies, Kirchberg, Switzerland) and for all participants the same neurofeedback-animation is used. NFB training duration is approx. 30min | Device | Healthy Subjects: Study 1, Healthy Subjects: Study 2, Healthy Subjects: Study 3 |
| Sham NeurofeedbackThe sham neurofeedback is performed in identical fashion using the same software, feedback, electrode placement, duration as in the real neurofeedback. Only difference is that a pre-recorded EEG-dataset will be used and the feedback signal is thus independent from the brain activity of the participant. | Device | Healthy Subjects: Study 1, Healthy Subjects: Study 2, Healthy Subjects: Study 3 |
Primary outcome
Functional brain connectivity
Time frame: 90 Minutes
Comparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)
7 secondary outcomes
Heart rate Variability Pre/Post Interventions
Time frame: 90 Minutes
Respiration frequency Pre/Post Interventions
Time frame: 90 Minutes
Heart rate variability during interventions
Time frame: 30 Minutes
Respiration frequency during interventions
Time frame: 30 Minutes
Electrodermal activity during interventions
Time frame: 30 Minutes
Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions
Time frame: 30 Minutes
Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions
Time frame: 30 Minutes
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 14 Feb 2025.
- Derived from this study: PubMed 41391628de Matos NMP, Stampfli P, Seifritz E, Brugger M. Disassembling infra-low-frequency neurofeedback: A neurophysiological investigation of its feedback components. Neuroimage. 2026 Jan;325:121647. doi: 10.1016/j.neuroimage.2025.121647. Epub 2025 Dec 12.
- Individual participant dataSharing planned: Undecided
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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.
Philipp Stämpfli, PD PhD principal investigator
Psychiatric University Hospital, Zurich
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 Neurofeedback in people with Neurofeedback, run by Philipp Stämpfli 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 4 inclusion and 9 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 14 Feb 2025. 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?
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?
Functional brain connectivity (time frame: 90 Minutes). 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 NCT05711550, 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 14 Feb 2025.