Neural Correlates of Repeated tDCS
2018年3月22日 更新者:Maastricht University Medical Center
Investigating the Neural Correlates of Repeated tDCS in MCI and Healthy Ageing With fMRI
Healthy ageing and pathological ageing in the context of a neurodegenerative disease are both associated with changes in brain network integrity.
Episodic memory is especially affected in Alzheimer's disease, but is also decreased in healthy ageing.
Consequently, the memory-relevant brain networks are especially altered.
Transcranial direct current stimulation (tDCS) has previously been implemented in different clinical- and non-clinical settings and has shown to beneficially influence network connectivity.
The neural correlates of single-session tDCS have been investigated, however, the neural effects of repeated tDCS remain unknown.
Furthermore, knowledge about the (long-term) neural mechanisms of repeated tDCS can give valuable insights and possibly pave the ground for exploring tDCS as a treatment option in future studies.
研究概览
研究类型
介入性
注册 (预期的)
80
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
-
-
Limburg
-
Maastricht、Limburg、荷兰、6221ET
- 招聘中
- Maastricht University
-
接触:
- Lisa Müller-Ehrenberg, MSc
- 电话号码:0031433881025
- 邮箱:l.muller-ehrenberg@maastrichtuniversity.nl
-
-
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
60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:
Patients
- Diagnosis of MCI based on the latest research criteria (clinical assessment at the memory clinic (prof. Frans RJ Verhey): presence of at least a memory impairment, memory complaints expressed by the patient or informant, no problems in daily life functioning, no dementia and presence of biomarkers (Albert et al., 2011)
- Clinical Dementia Rating score of 0.5 (CDR distinguishes a stage of questionable dementia (CDR 0.5) from people termed healthy (CDR 0) and those with mild dementia (CDR 1)
- Mini-Mental State Examination (MMSE) 23 and being mentally competent (in general, individuals with a MMSE 18 are considered mentally competent)
- Age: between 60 and 85 years old
- 50% female
- Right-handedness
- Average level of education (CBS level 3-4-5-6)
Healthy controls
- Average neuropsychological test results, in accordance with normative data, corrected for age, education and gender
- No substantial memory complaints (according to the participant)
- Age: between 60 and 85 years old
- 50% female
- Right-handedness
- Average level of education (CBS level 3-4-5-6)
- Normal or corrected to normal vision
Exclusion Criteria:
- Psychoactive medication use
- Abuse of alcohol and drugs
- Cognitive impairment due to alcohol/drug abuse or abuse of other substances
- Past or present psychiatric or neurological disorders (major depression, schizophrenia, bipolar disorder, psychotic disorder (or treatment for it), epilepsy, stroke, Parkinson's disease, multiple sclerosis, brain surgery, brain trauma, electroshock therapy, kidney dialysis, Menière's disease, brain infections)
- Major vascular disorders (e.g. stroke)
- Heart diseases or pacemakers
- Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, body tattoos)
- Large scars or fresh wounds on the scalp
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 |
|---|---|
|
实验性的:MCI-active
Patients will receive verum tDCS over the angular gyrus on five consecutive days.
|
Participants will receive active tDCS over the angular gyrus on five consecutive days
|
|
假比较器:MCI-sham
Patients will receive sham tDCS over the angular gyrus on five consecutive days.
|
Participants will receive sham tDCS over the angular gyrus on five consecutive days
|
|
实验性的:Healthy Old-active
Participants will receive verum tDCS over the angular gyrus on five consecutive days.
|
Participants will receive active tDCS over the angular gyrus on five consecutive days
|
|
假比较器:Healthy old-sham
Participants will receive sham tDCS over the angular gyrus on five consecutive days.
|
Participants will receive sham tDCS over the angular gyrus on five consecutive days
|
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 |
|---|---|---|
|
neural changes after multi-session tDCS
大体时间:5-12 days
|
fMRI-BOLD response
|
5-12 days
|
|
network changes after multi-session tDCS
大体时间:5-12 days
|
functional connectivity between network hubs
|
5-12 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Task performance changes after multi-session tDCS
大体时间:5-12 days
|
BPS-score
|
5-12 days
|
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。
调查人员
- 首席研究员:Heidi IL Jacobs, PhD、Maastricht University
- 学习椅:Frans RJ Verhey, Professor、Maastricht University
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5月2日
初级完成 (预期的)
2018年12月1日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2016年11月23日
首先提交符合 QC 标准的
2016年12月14日
首次发布 (估计)
2016年12月19日
研究记录更新
最后更新发布 (实际的)
2018年3月26日
上次提交的符合 QC 标准的更新
2018年3月22日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.