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临床试验/NCT06561165
NCT06561165
招募中
不适用

Personalizing Multifocal Transcranial Direct Stimulation Dose to Target the Motor Network in Older Adults

University of Michigan1 个研究点 分布在 1 个国家目标入组 40 人2025年2月25日

概览

阶段
不适用
干预措施
Functional Magnetic Resonance Imaging (fMRI)
疾病 / 适应症
Healthy
发起方
University of Michigan
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)
状态
招募中
最后更新
2个月前

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.

注册库
clinicaltrials.gov
开始日期
2025年2月25日
结束日期
2027年1月25日
最后更新
2个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Michael Vesia, PhD

Assistant Professor of Kinesiology

University of Michigan

入排标准

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

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)

HD-tDCS with standard intervention

Participants will have three daily sessions.

干预措施: Standard HD-tDCS intervention

Personalized dose-controlled multifocal network-targeted HD-tDCS.

Participants will have three daily sessions.

干预措施: Multifocal network targeted HD-tDCS intervention

Personalized dose-controlled multifocal network-targeted HD-tDCS.

Participants will have three daily sessions.

干预措施: Functional Magnetic Resonance Imaging (fMRI)

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)

研究点 (1)

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