Investigating the Neural Correlates of Repeated tDCS in MCI and Healthy Ageing With fMRI
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- neural changes after multi-session tDCS
研究概览
简要总结
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, Investigator)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
MCI-active
Patients will receive verum tDCS over the angular gyrus on five consecutive days.
干预措施: active tDCS (Device)
MCI-sham
Patients will receive sham tDCS over the angular gyrus on five consecutive days.
干预措施: sham tDCS (Device)
Healthy Old-active
Participants will receive verum tDCS over the angular gyrus on five consecutive days.
干预措施: active tDCS (Device)
Healthy old-sham
Participants will receive sham tDCS over the angular gyrus on five consecutive days.
干预措施: sham tDCS (Device)
结局指标
主要结局
neural changes after multi-session tDCS
时间窗: 5-12 days
fMRI-BOLD response
network changes after multi-session tDCS
时间窗: 5-12 days
functional connectivity between network hubs
次要结局
- Task performance changes after multi-session tDCS(5-12 days)