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

NCT ID: NCT05711550

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-13
• Study Completion Date: 2024-12-18

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.

Conditions

Neurofeedback

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Healthy Subjects: Study 1

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.

Group Type: EXPERIMENTAL

Real Neurofeedback

Intervention Type: 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

Intervention Type: 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.

Healthy Subjects: Study 2

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.

Group Type: EXPERIMENTAL

Real Neurofeedback

Intervention Type: 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

Intervention Type: 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.

Healthy Subjects: Study 3

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.

Group Type: EXPERIMENTAL

Real Neurofeedback

Intervention Type: 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

Intervention Type: 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.

Interventions

Real Neurofeedback

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

Intervention Type: DEVICE

Sham Neurofeedback

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.

Intervention Type: DEVICE

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philipp Stämpfli

OTHER

Sponsor Role: lead

Responsible Party

Philipp Stämpfli

Head of MR Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philipp Stämpfli, PD PhD

Role: PRINCIPAL_INVESTIGATOR

Psychiatric University Hospital, Zurich

Locations

Psychiatric University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

ILF_NFB_Allstudies

Identifier Type: -

Identifier Source: org_study_id