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Completed

NCT Number: NCT05711550

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

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.

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Key information

Conditions

Neurofeedback

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychiatric University Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Exclusion criteria met based on the screening questionnaire
  • 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

Treatment and study plan

Real Neurofeedback

Device

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 neurofeedback

Device

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.

Primary outcomes

  1. Functional brain connectivity

    Time frame: 90 Minutes

    Comparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)

Secondary outcomes

  1. Heart rate Variability Pre/Post Interventions

    Time frame: 90 Minutes

    Comparison of the Pre-Post intervention differences in heart rate variability (during fMRI measurements)

  2. Respiration frequency Pre/Post Interventions

    Time frame: 90 Minutes

    Comparison of the Pre-Post intervention differences in respiration frequency (during fMRI measurements)

  3. Heart rate variability during interventions

    Time frame: 30 Minutes

    Comparison of heart rate variability measured during both interventions (Neurofeedback and Sham Neurofeedback)

  4. Respiration frequency during interventions

    Time frame: 30 Minutes

    Comparison of respirateion frequency measured during both interventions (Neurofeedback and Sham Neurofeedback)

  5. Electrodermal activity during interventions

    Time frame: 30 Minutes

    Comparison of electrodermal activity (skin conductance) measured during both interventions (Neurofeedback and Sham Neurofeedback)

  6. Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions

    Time frame: 30 Minutes

    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)

  7. Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions

    Time frame: 30 Minutes

    Comparison of power spectral density (PSD) of low-frequency components (< 0.1Hz) recorded by the neurofeedback equipment during both interventions (Neurofeedback and Sham Neurofeedback)

Other outcomes

  1. Mental state pre/post intervention

    Time frame: 40 Minutes

    Participants complete a questionnaire immediately before and after intervention for assessment of participants' mental state pre and immediately after the interventions

  2. Sleep questionnaire

    Time frame: 24 Hours

    Questionnaires 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.

  3. Personality questionnaires

    Time frame: 10 Minutes

    BFI-60 personality questionnaire will be completed by participants at the beginning of each experimental visit to assess interactions between personality attributes and other outcomes

Sponsors and collaborators

Lead sponsor

Philipp Stämpfli

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2023
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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