Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
2019年1月4日 更新者：University Hospital, Grenoble
Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
The main objective of this study is to estimate the effect of the neuromodulation on the behavioral performances during the access in semantics according to the age of the individuals.
Neuromodulation by non-invasive stimulation allows to explore the functioning of the brain by exciting or by inhibiting localized cortical zones. The modulation of the performances in cognitive tasks, further to the neuromodulation of these zones, allows to deduce on their functional roles.
研究概览
地位
未知
详细说明
The objective of this project is to determine the changes of behavioral performances (time of answer, percentage of correct answers) further to the neuromodulation.
The specific question is to estimate the effect on the performances of access at the semantic representations of this method, according to the age.
One of the hypotheses in the research on the normal ageing is the difficulty of access to these representations (fundamental process for the cognitive functions, such as the language and the memory) at the healthy elderly.
By using the neuromodulation the investigators wish to explore this hypothesis and to understand if the neuromodulation can have a beneficial effect on the improvement of the behavioral performances of the elderly.
研究类型
介入性
注册 (预期的)
120
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Grenoble、法国、38043
- 招聘中
- CHU
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接触：
- Laurent TORLAY
- 邮箱：laurent.torlay@univ-grenoble-alpes.fr
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接触：
- Thierry BOUGEROL
- 邮箱：TBougerol@chu-grenoble.fr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Major healthy Subject ( 18 - 85 years)
- Right-hander
- Signed Informed consent
- A medical examination must be made before the participation for the research
- Membership in or beneficiary of a national insurance scheme
Non inclusion Criteria:
- Subject under age 18 and of more than 85 years.
- Contraindications in the practice of MRI, TMS and tES
- Existence of a severe affection on the general plan: cardiac, respiratory, hematological, renal, hepatic, cancerous
- Regular taking of anxiolytic, sedative, antidepressant, neuroleptic
- Characterized psychiatric pathology
- Ingestion of alcohol before the examination
- Pregnancy, parturiency or breast-feeding
- Private person of freedom by court or administrative order, nobody being the object of a legal protective measure (under guardianship or guardianship)
- Participation to other protocols of current search with period of exclusion or in the previous week
- Subject which would perceive more than 4500 euros of compensation because of its participation in other searches involving the human person in 12 months preceding this study.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：18-49 years group
Participants undergo 2 sessions of MRI + transcranial Magnetic Stimulation or transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
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Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
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|
实验性的：50-85 years group
Participants undergo 2 sessions of MRI + transcranial Magnetic Stimulation or transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
|
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram.
The 2 sessions are performed with an interval of 3 to 7 days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effect of the neuromodulation on the behavioral performances during the access in semantics
大体时间：3 hours
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Evaluation of the changes of the behavioral performances before and after the neuromodulation by non-invasive cortical stimulation according to the age.
More exactly, the investigators shall compare response times before and after neuromodulation between both age groups (18-49 years and 50-85 years), by testing the interaction between the effect of the neuromodulation and the age.
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3 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Estimate the effect of the neuromodulation on the behavioral performances
大体时间：3 hours
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Compare the percentages of correct answers before and after neuromodulation by non-invasive cortical electric stimulation, according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.
大体时间：3 hours
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Comparison of the neuropsychological scores before and after tES, according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of tES on the cerebral functional activity, by comparing blood-oxygen-level dependent (BOLD ) signal or functional MRI before and after tES according to the age (18-49 years vs 50-85 years).
大体时间：3 hours
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The investigators extract estimates parameters (Estimated Beta weight Values) corresponding to each tES stimulation.
Each session is be designed by using general linear model (Friston, 1998, statistical parametrical mapping in fMRI) defined as Ybefore tES = R1Beta1+R2Beta2 +R0Beta0 + e and Yafter tES = R1Beta1 +R2Beta2 +R0Beta0 + e, with Y = acquired BOLD signal, e = error, R1Beta1 corresponding to the task (meaning interest activation) regressor and R2Beta2 corresponding to the control (meaning no interest activation) regressor respectively convolved with the canonical hemodynamic response function (cHRf) and R0B0 corresponding to the constant regressor.
Parameter estimates are calculated by extracting Beta1 and Beta2 values for each session respectively in order to compute statistical comparison (measure by subject) on the outcome measure (Beta1 before tES - Beta1 after tES).
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3 hours
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Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.
大体时间：3 hours
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Comparison of the neuropsychological scores before and after Transcranial Magnetic Stimulation (TMS), according to the age (18-49 years vs 50-85 years).
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3 hours
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Estimate the effect of the TMS on the intellectual functional activity, according to the age.
大体时间：3 hours
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Comparison of the cerebral functional activity (electric neuronal signal, EEG) before and after TMS, according to the age (18-49 years vs 50-85 years).
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3 hours
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Zimerman M, Hummel FC. Non-invasive brain stimulation: enhancing motor and cognitive functions in healthy old subjects. Front Aging Neurosci. 2010 Dec 1;2:149. doi: 10.3389/fnagi.2010.00149. eCollection 2010.
- Holland R, Leff AP, Josephs O, Galea JM, Desikan M, Price CJ, Rothwell JC, Crinion J. Speech facilitation by left inferior frontal cortex stimulation. Curr Biol. 2011 Aug 23;21(16):1403-7. doi: 10.1016/j.cub.2011.07.021. Epub 2011 Aug 4.
- Monti A, Ferrucci R, Fumagalli M, Mameli F, Cogiamanian F, Ardolino G, Priori A. Transcranial direct current stimulation (tDCS) and language. J Neurol Neurosurg Psychiatry. 2013 Aug;84(8):832-42. doi: 10.1136/jnnp-2012-302825. Epub 2012 Nov 8.
- Liuzzi G, Freundlieb N, Ridder V, Hoppe J, Heise K, Zimerman M, Dobel C, Enriquez-Geppert S, Gerloff C, Zwitserlood P, Hummel FC. The involvement of the left motor cortex in learning of a novel action word lexicon. Curr Biol. 2010 Oct 12;20(19):1745-51. doi: 10.1016/j.cub.2010.08.034. Epub 2010 Sep 30.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月31日
初级完成 (预期的)
2020年6月1日
研究完成 (预期的)
2020年6月1日
研究注册日期
首次提交
2017年4月18日
首先提交符合 QC 标准的
2017年5月23日
首次发布 (实际的)
2017年5月30日
研究记录更新
最后更新发布 (实际的)
2019年1月8日
上次提交的符合 QC 标准的更新
2019年1月4日
最后验证
2019年1月1日
更多信息
与本研究相关的术语
其他研究编号
- 38RC17.078
- 2017-A00834-49 (其他标识符：ansm)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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