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临床试验/NCT04062318
NCT04062318
已完成
不适用

The Causal Role of Neocortical Beta Events in Human Sensory Perception

Brown University1 个研究点 分布在 1 个国家目标入组 39 人2019年7月25日

概览

阶段
不适用
干预措施
Online Active SI-Hand TMS
疾病 / 适应症
Beta Rhythm
发起方
Brown University
入组人数
39
试验地点
1
主要终点
Threshold-Level Tactile Detection Hit Rate
状态
已完成
最后更新
2个月前

概览

简要总结

Low-frequency brain rhythms in the alpha (8-14Hz) and beta (15-29Hz) bands are strong predictors of perception and functional performance in a range of tasks, and are disrupted in several disease states. The purpose of this study is to investigate a direct causal relationship between low-frequency brain rhythms and sensory perception, and to optimize commonly used TMS paradigms to impact sensory processing and perception in a similar manner as endogenous rhythms. To do so, this study combines human magnetic resonance imaging (MRI), electroencephalography (EEG), non-invasive brain stimulation (transcranial magnetic stimulation; TMS), and biophysically principled computational neural modeling.

详细描述

Prior studies have shown that high power low-frequency brain rhythms in the alpha (8-14) and beta (15-29 Hz) bands in primary somatosensory cortex (SI) are associated with a decreased probability of perceiving tactile stimuli at perceptual threshold, and can be modulated with attention. Furthermore, high power beta activity in SI emerges as brief "events" (\<150ms) in un-averaged data, the rate and timing of which underlie the attentional and perceptual effects associated with high beta power. In this study, human electroencephalography (EEG) and a non-painful tactile detection task are used to assess if TMS that is hypothesized to mimic endogenous beta-frequency events impact touch perception in a similar manner. The TMS-EEG components of this study will use a within-subjects crossover design. In initial study sessions, all participants will have an MRI. In subsequent study sessions, participants will complete a tactile detection task while EEG data is recorded concurrent with online active, active control or sham control TMS. Analyses will focus on comparing detection probabilities of tactile stimuli presented at perceptual threshold and tactile evoked response potential waveforms between trials with and without concurrent TMS.

注册库
clinicaltrials.gov
开始日期
2019年7月25日
结束日期
2024年11月2日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Ability to provide informed consent/assent
  • Age: 18-65 years
  • English fluency: participants must be able to understand screening questionnaires and task instructions spoken/written in English.
  • Right handed: to reduce heterogeneity related to hand dominance, since our task involves touch perception on the hand, and examination of neural correlates in lateralized brain regions.

排除标准

  • History of fainting spells of unknown or undetermined etiology that might constitute seizures
  • History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
  • Any progressive (e.g., neurodegenerative) neurological disorder
  • Chronic medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)
  • Metal implants (excluding dental fillings)
  • Pacemaker
  • Implanted medication pump or cochlear implant
  • Vagal nerve stimulator
  • Deep brain stimulator
  • TENS unit (unless removed completely for the study)

研究组 & 干预措施

Active SI-Hand TMS vs. Active Control TMS

Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, active TMS is applied over a control brain region, in a more superior and lateral location within SI.

干预措施: Online Active SI-Hand TMS

Active SI-Hand TMS vs. Active Control TMS

Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, active TMS is applied over a control brain region, in a more superior and lateral location within SI.

干预措施: Online Active Control TMS

Active SI-Hand TMS vs. Sham SI-Hand TMS

Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, sham TMS is applied over the same target location (SI-Hand)

干预措施: Online Active SI-Hand TMS

Active SI-Hand TMS vs. Sham SI-Hand TMS

Participants receive perceptual threshold-level tactile stimuli to the third digit of the right hand and report detection or non-detection. EEG is recorded and TMS is applied concurrently during the task. In one study session, active TMS is applied over the hand region of primary somatosensory cortex (SI-Hand). In another study session, sham TMS is applied over the same target location (SI-Hand)

干预措施: Online Sham SI-Hand TMS

结局指标

主要结局

Threshold-Level Tactile Detection Hit Rate

时间窗: Tactile detection was assessed between TMS and no TMS trials continuously during the TMS interventions - during the Active SI TMS session, and during either the Active Control TMS or Sham Control TMS session. The sessions were at least 1 week apart.

Participants receive one or zero tactile stimuli per trial and report detection or non-detection using a button press. Tactile stimuli are delivered at participants' individual perceptual threshold level (perceived roughly half the time). On a given trial, TMS may also be delivered 100 msec before the tap ('TMS100'), 25 msec after the tap ('TMS25'), or not at all ('TMS Null'), each for an equal number of trials. The 'hit rate' is defined as the number of trials with correctly detected tactile stimuli divided by the total number of trials on which a tactile stimulus was presented.

次要结局

  • EEG Tactile Evoked Response Potential (ERP)(EEG measures were assessed between TMS and no TMS trials continuously during the TMS interventions - during the Active SI TMS session, and during either the Active Control TMS or Sham Control TMS session. The sessions were at least 1 week apart.)

研究点 (1)

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