Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage change in the time to complete the nine-hole peg test (9-HPT)
研究概览
简要总结
The purpose of this study is to understand how the brain controls movement and how Non-invasive Brain Stimulation (NIBS) with a technique called High-density transcranial direct current stimulation (HD-tDCS) can alter brain processes to improve behavior. Participants in this study will be randomized to either HD-tDCS with standard intervention or personalized dose-controlled multifocal network-targeted HD-tDCS.
The hypothesis is that dexterous hand function will improve after a standard HD-tDCS dose and increase even more after personalized dose-controlled multifocal network-targeted HD-tDCS.
详细描述
This project is the first of two projects. The second project will be registered as a separate project in the future and enroll participants from this project.
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
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants should be in good health with normal or corrected-to-normal visual acuity
- •Right handed
- •No history of neurological disorder
- •English speaker
- •Able to provide written consent prior to admission
排除标准
- •Left-handed
- •Participants are pregnant, suspect pregnancy or are attempting to become pregnant
- •Have a pacemaker, intracardiac lines or any other medically implanted device or medicine pump
- •Have cochlear hearing implants
- •Taking drugs known to influence neural receptors that facilitate neuroplasticity (see protocol)
- •Have non removable body piercings or have foreign objects in body
- •Have metal anywhere in the head that could increase risk of serious injury (not including braces, dental fillings, etc.) (see protocol)
- •Have a personal or family history of seizure/epilepsy
- •Taking prescription drugs that lower the threshold for seizures
- •Recent history of excessive alcohol consumption
- •History of alcohol addiction/dependence
- •Recent history of recreational drug use
- •History of drug addiction/dependence
- •Recent history of recreational drug use
- •History of drug addiction/dependence
- •Diagnosed with a stroke, brain hemorrhage, brain tumor, encephalitis.
- •Diagnosed with multiple sclerosis
- •Diagnosed with Parkinson's disease or Alzheimer's disease
- •Diagnosed with depression in the past 6 months
- •Diagnosed with attention deficit disorder, schizophrenia, manic depressive (bipolar) disorder
- •Diagnosed with normal pressure hydrocephalus or increased intra-cranial pressure
- •Diabetes requiring insulin treatment
- •Any serious heart disorder or liver disease
研究组 & 干预措施
HD-tDCS with standard intervention
Participants will have three daily sessions.
干预措施: Functional Magnetic Resonance Imaging (fMRI) (Device)
HD-tDCS with standard intervention
Participants will have three daily sessions.
干预措施: Standard HD-tDCS intervention (Device)
Personalized dose-controlled multifocal network-targeted HD-tDCS.
Participants will have three daily sessions.
干预措施: Multifocal network targeted HD-tDCS intervention (Device)
Personalized dose-controlled multifocal network-targeted HD-tDCS.
Participants will have three daily sessions.
干预措施: Functional Magnetic Resonance Imaging (fMRI) (Device)
结局指标
主要结局
Percentage change in the time to complete the nine-hole peg test (9-HPT)
时间窗: Baseline and 24 hours after the third sessions are completed
9-hole peg test is a manual dexterity measure, estimated as the time required to complete the task (seconds).
Percent change in precision force-tracking task
时间窗: Baseline and 24 hours after the third sessions are completed
Squared distance (error) from the cursor to the target in precision force-tracking task, estimated as the root mean squared error (RMSE).
次要结局
- Percentage change in the mean choice reaction time(Baseline and 24 hours after the third sessions are completed)
研究者
Michael Vesia, PhD
Assistant Professor of Kinesiology
University of Michigan