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

Neurofeedback Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711550
• Other study ID #: ILF_NFB_Allstudies
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2023
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Psychiatric University Hospital, Zurich
• Contact: Philipp Stämpfli, PD PhD
• Phone: +41 58 384 27 38
• Email: philipp.staempfli[@]bli.uzh.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurofeedback

Intervention

Device:
• 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
• 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.

Locations

Country	Name	City	State
Switzerland	Psychiatric University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Philipp Stämpfli

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mental state pre/post intervention	Participants complete a questionnaire immediately before and after intervention for assessment of participants' mental state pre and immediately after the interventions	40 Minutes
Other	Sleep questionnaire	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.	24 Hours
Other	Personality questionnaires	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	10 Minutes
Primary	Functional brain connectivity	Comparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)	90 Minutes
Secondary	Heart rate Variability Pre/Post Interventions	Comparison of the Pre-Post intervention differences in heart rate variability (during fMRI measurements)	90 Minutes
Secondary	Respiration frequency Pre/Post Interventions	Comparison of the Pre-Post intervention differences in respiration frequency (during fMRI measurements)	90 Minutes
Secondary	Heart rate variability during interventions	Comparison of heart rate variability measured during both interventions (Neurofeedback and Sham Neurofeedback)	30 Minutes
Secondary	Respiration frequency during interventions	Comparison of respirateion frequency measured during both interventions (Neurofeedback and Sham Neurofeedback)	30 Minutes
Secondary	Electrodermal activity during interventions	Comparison of electrodermal activity (skin conductance) measured during both interventions (Neurofeedback and Sham Neurofeedback)	30 Minutes
Secondary	Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions	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)	30 Minutes
Secondary	Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions	Comparison of power spectral density (PSD) of low-frequency components (< 0.1Hz) recorded by the neurofeedback equipment during both interventions (Neurofeedback and Sham Neurofeedback)	30 Minutes