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Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome

Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05711550
Enrollment
120
Registered
2023-02-03
Start date
2023-01-13
Completion date
2024-12-18
Last updated
2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofeedback

Keywords

Neurofeedback, fMRI, resting-state

Brief 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. 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.

Interventions

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

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.

Sponsors

Philipp Stämpfli
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 *

Design outcomes

Primary

MeasureTime frameDescription
Functional brain connectivity90 MinutesComparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)

Secondary

MeasureTime frameDescription
Heart rate variability during interventions30 MinutesComparison of heart rate variability measured during both interventions (Neurofeedback and Sham Neurofeedback)
Electrodermal activity during interventions30 MinutesComparison of electrodermal activity (skin conductance) measured during both interventions (Neurofeedback and Sham Neurofeedback)
Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions30 MinutesComparison 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)
Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions30 MinutesComparison of power spectral density (PSD) of low-frequency components (\< 0.1Hz) recorded by the neurofeedback equipment during both interventions (Neurofeedback and Sham Neurofeedback)
Heart rate Variability Pre/Post Interventions90 MinutesComparison of the Pre-Post intervention differences in heart rate variability (during fMRI measurements)
Respiration frequency Pre/Post Interventions90 MinutesComparison of the Pre-Post intervention differences in respiration frequency (during fMRI measurements)
Respiration frequency during interventions30 MinutesComparison of respirateion frequency measured during both interventions (Neurofeedback and Sham Neurofeedback)

Other

MeasureTime frameDescription
Personality questionnaires10 MinutesBFI-60 personality questionnaire will be completed by participants at the beginning of each experimental visit to assess interactions between personality attributes and other outcomes
Mental state pre/post intervention40 MinutesParticipants complete a questionnaire immediately before and after intervention for assessment of participants' mental state pre and immediately after the interventions
Sleep questionnaire24 HoursQuestionnaires on sleep quality will be given to the participants at the beginning of each experimental visit and within 24 hours after participation in order to assess effects of the interventions on sleep quality.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026