Clinical trial NCT05711550: Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome
Official title: Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurofeedback
Keywords: Neurofeedback, fMRI, resting-state
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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
* 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

Primary outcomes:
measure: Functional brain connectivity
timeFrame: 90 Minutes
Secondary outcomes:
measure: Heart rate Variability Pre/Post Interventions
timeFrame: 90 Minutes
measure: Respiration frequency Pre/Post Interventions
timeFrame: 90 Minutes
measure: Heart rate variability during interventions
timeFrame: 30 Minutes
measure: Respiration frequency during interventions
timeFrame: 30 Minutes
measure: Electrodermal activity during interventions
timeFrame: 30 Minutes
measure: Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions
timeFrame: 30 Minutes
measure: Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions
timeFrame: 30 Minutes
Other outcomes:
measure: Mental state pre/post intervention
timeFrame: 40 Minutes
measure: Sleep questionnaire
timeFrame: 24 Hours
measure: Personality questionnaires
timeFrame: 10 Minutes
Locations:
city: Zurich
country: Switzerland
facility: Psychiatric University Hospital Zurich
Study officials:
affiliation: Psychiatric University Hospital, Zurich
name: Philipp Stämpfli, PD PhD
role: PRINCIPAL_INVESTIGATOR
References: