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

Not Applicable

Completed

• Conditions: Neurofeedback
• Interventions: Device: Real Neurofeedback; Device: Sham Neurofeedback

• Registration Number: NCT05711550
• Lead Sponsor: Philipp Stämpfli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-13
• Study First Submitted: 2023-01-13
• Study First Submitted QC: 2023-01-31
• Study First Posted: 2023-02-03
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-18
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Subjects: Study 1	Real Neurofeedback	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.
Healthy Subjects: Study 1	Sham Neurofeedback	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.
Healthy Subjects: Study 3	Sham Neurofeedback	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.
Healthy Subjects: Study 2	Sham Neurofeedback	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.
Healthy Subjects: Study 2	Real Neurofeedback	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.
Healthy Subjects: Study 3	Real Neurofeedback	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.

Primary Outcome Measures

Name	Time	Method
Functional brain connectivity	90 Minutes	Comparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)

Secondary Outcome Measures

Name	Time	Method
Heart rate Variability Pre/Post Interventions	90 Minutes	Comparison of the Pre-Post intervention differences in heart rate variability (during fMRI measurements)
Respiration frequency Pre/Post Interventions	90 Minutes	Comparison of the Pre-Post intervention differences in respiration frequency (during fMRI measurements)
Electrodermal activity during interventions	30 Minutes	Comparison of electrodermal activity (skin conductance) measured during both interventions (Neurofeedback and Sham Neurofeedback)
Heart rate variability during interventions	30 Minutes	Comparison of heart rate variability measured during both interventions (Neurofeedback and Sham Neurofeedback)
Respiration frequency during interventions	30 Minutes	Comparison of respirateion frequency 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 interventions	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)
Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions	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)

Trial Locations

Locations (1)

Psychiatric University Hospital Zurich; 🇨🇭 Zurich, Switzerland