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临床试验/NCT05847829
NCT05847829招募中不适用

T-REEX: Phase Locked TRanscranial Electrical EXcitation

Stichting IMEC-NL2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
2
主要终点
The phase difference (error) between the estimated phase of EEG activity and the phase of the delivered stimulation at the target locationor EEG readout and tCS stimulation

研究概览

简要总结

Transcranial current stimulation (tCS) has been extensively studied due to its potential of selectively stimulate brain regions in a non-invasive way. However, classic stimulation paradigms are often applied in an open loop configuration, without considering the effects on the underlying brain activity.

Recent studies suggest that when alternating current are used, it would be beneficial to phase lock the stimulation to the target brain wave of interest to achieve selective temporal stimulation, allowing for better control over the stimulation effects.

This study aims at demonstrating a novel setup that allows for precise stimulation targeted in space and time. To achieve that, a combination of tCS and (EEG phased locked) closed-loop modality are used to obtain the required selectivity.

研究设计

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

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Signed informed consent
  • Age between 18 and 64

排除标准

  • Wounded or particular sensitive skin at areas of investigation. For example, skinrash, discoloration, scars, or open wounds
  • Allergies to adhesive or dry electrodes or silver chloride
  • Pregnant or lactating
  • Any of the following symptoms (fever, tiredness, dry cough, aches and pains, nasal congestion, runny nose, sore throat, diarrhoea)
  • Known neurological disorders
  • Previous epileptic episodes
  • Active implants such as pacemakers or brain stimulators
  • Intracranial metal implants

结局指标

主要结局

The phase difference (error) between the estimated phase of EEG activity and the phase of the delivered stimulation at the target locationor EEG readout and tCS stimulation

时间窗: 2 hours

次要结局

  • the amount of phase and/or amplitude change in the brain wave of interest (e.g., 10 Hz alpha activity) resulting from different tCS modalities and stimulation parameters used(2 hours)

研究者

发起方
Stichting IMEC-NL
申办方类型
Other
责任方
Sponsor

研究点 (2)

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