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

NCT05711550 | Completed

• 1 other identifier: ILF_NFB_Allstudies
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Neurofeedback, fMRI, resting-state

Outcome Measures

Primary Outcomes (1)

• Functional brain connectivity

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

  90 Minutes

Secondary Outcomes (7)

• Heart rate Variability Pre/Post Interventions

  90 Minutes

• Respiration frequency Pre/Post Interventions

  90 Minutes

• Heart rate variability during interventions

  30 Minutes

• Respiration frequency during interventions

  30 Minutes

• Electrodermal activity during interventions

  30 Minutes

Other Outcomes (3)

• Mental state pre/post intervention

  40 Minutes

• Sleep questionnaire

  24 Hours

• Personality questionnaires

  10 Minutes

Study Arms (3)

Healthy Subjects: Study 1

EXPERIMENTAL

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.

Device: Real Neurofeedback; Device: Sham Neurofeedback

Healthy Subjects: Study 2

EXPERIMENTAL

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.

Device: Real Neurofeedback; Device: Sham Neurofeedback

Healthy Subjects: Study 3

EXPERIMENTAL

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.

Device: Real Neurofeedback; Device: Sham Neurofeedback

Interventions

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

Healthy Subjects: Study 1; Healthy Subjects: Study 2; Healthy Subjects: Study 3

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.

Healthy Subjects: Study 1; Healthy Subjects: Study 2; Healthy Subjects: Study 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipp Stämpfli: lead

Study Sites (1)

Psychiatric University Hospital Zurich

Zurich, Canton of Zurich, 8032, Switzerland

Location

Study Officials

• Philipp Stämpfli, PD PhD

  Psychiatric University Hospital, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of MR Center

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 3, 2023
• Study Start: January 13, 2023
• Primary Completion: December 18, 2024
• Study Completion: December 18, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CH (1)