Neuromodulation by Non-invasive Brain Stimulation (NEUROMOD)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Effect of the neuromodulation on the behavioral performances during the access in semantics
研究概览
简要总结
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.
详细描述
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, Outcomes Assessor)
盲法说明
Each participant is included for 2 neuromodulation sessions: one session where neurostimulation is effective, one session where neurostimulation is simulated. Sessions are performed blind for the participant and the outcome assessor.
Sessions order is randomized for each participant (no arm randomization).
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: MRI + transcranial Magnetic Stimulation (Other)
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.
干预措施: transcranial electric stimulation + electroencephalogram (Other)
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.
干预措施: MRI + transcranial Magnetic Stimulation (Other)
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.
干预措施: transcranial electric stimulation + electroencephalogram (Other)
结局指标
主要结局
Effect of the neuromodulation on the behavioral performances during the access in semantics
时间窗: 3 hours
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.
次要结局
- 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).(3 hours)
- Estimate the effect of transcranial Electrical Stimulation (tES) on the cognitive performances by neuropsychological scores, according to the age.(3 hours)
- Estimate the effect of the Transcranial Magnetic Stimulation (TMS) on the cognitive performances by neuropsychological scores, according to the age.(3 hours)
- Estimate the effect of the TMS on the intellectual functional activity, according to the age.(3 hours)
- Estimate the effect of the neuromodulation on the behavioral performances(3 hours)