Investigating the Effect of Normal Frequency-band and Infra-low Frequency Neurofeedback on Functional Brain Connectome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Functional brain connectivity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent after participants' information
- •Fluent in German language (required for an adequate answering of the questionnaires)
- •No previous experience with neurofeedback treatments
排除标准
- •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
结局指标
主要结局
Functional brain connectivity
时间窗: 90 Minutes
Comparison of the Pre-Post intervention differences in resting state functional connectivity (assessed using fMRI)
次要结局
- Heart rate Variability Pre/Post Interventions(90 Minutes)
- Respiration frequency Pre/Post Interventions(90 Minutes)
- Electrodermal activity during interventions(30 Minutes)
- Heart rate variability during interventions(30 Minutes)
- Respiration frequency during interventions(30 Minutes)
- Power spectrum density (PSD) of the delta, theta, alpha, beta and gamma bands in the EEG-signal recorded during interventions(30 Minutes)
- Power spectrum density (PSD) of low-frequency components (< 0.1Hz) in the EEG-signal recorded during interventions(30 Minutes)
研究者
Philipp Stämpfli
Head of MR Center
Psychiatric University Hospital, Zurich