跳至主要内容
临床试验/NCT05570695
NCT05570695已完成不适用

How do Alpha Oscillations Shape the Perception of Pain? - An EEG-based Neurofeedback Study

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
2
主要终点
Alpha asymmetry index (AAI) during neurofeedback

研究概览

简要总结

Pain is closely linked to alpha oscillations (8 -13 Hz) which are thought to represent a supra-modal, top-down mediated gating mechanism that shapes sensory processing. Consequently, alpha oscillations might also shape the cerebral processing of nociceptive input and eventually the perception of pain. To test this mechanistic hypothesis, the investigators designed a sham-controlled and double-blind electroencephalography (EEG)-based neurofeedback study. In a short-term neurofeedback training protocol, healthy participants will learn to up- and downregulate somatosensory alpha oscillations using attention. Subsequently, the investigators will investigate how this manipulation impacts experimental pain applied during neurofeedback. Using Bayesian statistics and mediation analysis, the investigators will test whether alpha oscillations mediate attention effects on pain perception. This approach promises causal insights into the role of alpha oscillations in shaping pain, and thereby extends previous correlative evidence. Beyond, it can aid the development of novel, non-invasive modulatory treatment approaches for chronic pain, which are urgently needed.

The prosed study protocol has been granted in-principle acceptance from PLOS Biology and the corresponding registration can be found at the OSF online repository [www.osf.io/qbkj2\].

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

Double-blinding will be enabled through the usage of sham conditions which comprise an identical sequence of events as the verum conditions and participant-specific numeric codes encoding the order of conditions. During each session, these codes will automatically (1) determine the predefined training conditions and (2) generate file names. Thus, the experimenter will be blinded during data acquisition as well as during subsequent preprocessing and analysis steps.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • aged 18-45 years
  • right-handedness (laterality quotient > 60 on the Edinburgh handedness inventory)
  • good command of German
  • written informed consent
  • attendance at both sessions and compliance with instructions throughout the experiment

排除标准

  • pregnancy
  • neurological or psychiatric diseases (e.g., epilepsy, stroke, depression, anxiety disorders)
  • severe general illnesses (e.g., tumors, diabetes)
  • skin diseases (e.g., dermatitis, psoriasis or eczema)
  • current or recurrent pain
  • regular intake of medication (aside from contraception, thyroidal, and antiallergic medication)
  • surgical procedures involving the head or spinal cord
  • side-effects following previous thermal stimulation
  • contact to a person with a SARS-CoV-2 infection within the last 2 weeks
  • current symptoms of a cold or flu

结局指标

主要结局

Alpha asymmetry index (AAI) during neurofeedback

时间窗: During procedure (neurofeedback)

During neurofeedback, brain activity will be recorded continuously and the AAI will be extracted. Subsequently, AAIs will be compared between neurofeedback conditions. Details regarding the complete analysis pipeline can be found at the OSF online repository \[www.osf.io/qbkj2\].

Pain ratings during neurofeedback (NRS; 1: 'no pain' to 100: 'worst tolerable pain')

时间窗: During procedure (neurofeedback)

At the end of each neurofeedback trial, participants will verbally rate the perceived intensity of a cutaneous laser stimulus. Subsequently, pain ratings will be compared between neurofeedback conditions. Details regarding the complete analysis pipeline can be found at the OSF online repository \[www.osf.io/qbkj2\].

Pain-related brain responses during neurofeedback

时间窗: During procedure (neurofeedback)

During neurofeedback, brain activity will be recorded continuously, and the pain-related brain responses will be extracted. Subsequently, pain-related brain responses will be compared between neurofeedback conditions. Details regarding the complete analysis pipeline can be found at the OSF online repository \[www.osf.io/qbkj2\].

次要结局

  • Perceived task demand (NRS; 1: 'very low' to 7: 'very high')(After each condition)
  • Effort exerted (NRS; 1: 'very low' to 7: 'very high')(After each condition)
  • Motivation to participate in the training measured by a numerical rating scale (NRS; 1: 'very low' to 7: 'very high')(Before each session)
  • Health-related locus of control (Multidimensional Health Locus of Control Scales, MHLC, minimum score: 3, maximum score: 15)(Before each session)
  • Current positive or negative affect (Positive and Negative Affect Schedule, PNAS, minimum score: 10, maximum score: 50)(Before each session)
  • General self-efficacy (German version of the General Self-Efficacy Scale, GSE, minimum score: 10, maximum score: 40)(Before each session)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Markus Ploner

Professor of Human Pain Research

Technical University of Munich

研究点 (2)

Loading locations...

相似试验