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

Philipp Stämpfli

Status: Completed

Conditions: Neurofeedback

Treatments: Device: Sham Neurofeedback; Device: Real Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05711550

ILF_NFB_Allstudies

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Healthy Subjects: Study 1

Experimental group

Description:

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.

Treatment:

Device: Real Neurofeedback

Device: Sham Neurofeedback

Healthy Subjects: Study 2

Experimental group

Description:

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.

Treatment:

Device: Real Neurofeedback

Device: Sham Neurofeedback

Healthy Subjects: Study 3

Experimental group

Description:

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.

Treatment:

Device: Real Neurofeedback

Device: Sham Neurofeedback