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临床试验/NCT06491264
NCT06491264
撤回
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Concurrent Multiparameter Optimized Noninvasive Brain Stimulation for Working Memory in Aging

Medical University of South Carolina0 个研究点目标入组 25 人2026年12月31日

概览

阶段
不适用
干预措施
Transcranial electrical stimulation
疾病 / 适应症
Healthy Aging
发起方
Medical University of South Carolina
入组人数
25
主要终点
Electrocortical EEG changes pre- to post-tES
状态
撤回
最后更新
2个月前

概览

简要总结

With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. Transcranial electrical stimulation (tES) is a promising but not fully realized noninvasive brain stimulation approach that could improve memory. This study investigates the behavioral and electrocortical effects of personalized tES in aging to determine whether whether optimal dosing, electrode placements, and waveforms elicit stronger responses.

详细描述

With an aging population worldwide, it is critical to develop effective interventions promoting healthy cognitive aging. A key component of healthy cognition is intact working memory, an executive neural process holding information temporarily. With increasing age, working memory capacity decreases and is associated with a loss of independence, thus incentivizing the need to retain a healthy working memory capacity. In addition to facilitating healthy aging, developing a method that improves working memory could help those diagnosed with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), which is currently is the 6th leading cause of death in the US and has an annual economic burden of $305 billion. A potential approach to improve working memory is transcranial electrical stimulation (tES), a noninvasive brain stimulation method using scalp electrodes to deliver low electrical currents of 2 milliamps (mA) over the cortical target. While some prior studies have shown that prefrontal tES can improve working memory in older adults, there are small meta-analytic effect sizes and no FDA-approved indications to date. These mixed results could be due to applying one-size-fits-all and suboptimal tES parameters. In this study, the investigators will test the effects of personalized parameters, including dosing, electrode positioning, and waveforms compared to standard tES and placebo.

注册库
clinicaltrials.gov
开始日期
2026年12月31日
结束日期
2027年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

责任方
Principal Investigator
主要研究者

Kevin Caulfield

Assistant Professor

Medical University of South Carolina

入排标准

入选标准

  • 50 - 85 y.o.
  • Endorse good health with no history of mental or physical illness
  • Willingness to adhere to the study schedule and assessments
  • Able to read consent document and provide informed consent.
  • English is a first or primary fluent language.

排除标准

  • Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness \> 1
  • Neurodevelopmental disorders, history of Central Nervous System (CNS) disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain
  • Any psychotropic medication is taken within 5 half-lives of procedure time
  • Any head trauma resulting in loss of consciousness
  • Visual impairment (except the use of glasses)
  • Inability to complete cognitive testing
  • Active participation or plan for enrollment in another evidence-based clinical trial affecting the psychosocial function
  • Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids
  • Implanted devices/ferrous metal of any kind
  • History of seizure or epilepsy, currently taking medications that lower seizure thresholds

研究组 & 干预措施

Personalized tES stimulation #1

tES will be applied with personalized parameters in condition #1 for approximately 20 minutes.

干预措施: Transcranial electrical stimulation

Personalized tES stimulation #2

tES will be applied with personalized parameters in condition #2 for approximately 20 minutes.

干预措施: Transcranial electrical stimulation

Personalized tES stimulation #3

tES will be applied with personalized parameters in condition #3 for approximately 20 minutes.

干预措施: Transcranial electrical stimulation

Standard tES

Standard tES will be applied in condition #4 for approximately 20 minutes.

干预措施: Transcranial electrical stimulation

Sham tES stimulation

A sham (placebo) comparison condition will be applied in condition #5 for approximately 20 minutes.

干预措施: Transcranial electrical stimulation

结局指标

主要结局

Electrocortical EEG changes pre- to post-tES

时间窗: 1 year

Observe effects of each tES condition within each of the 5 sessions, as measured by TMS-EEG

N-back working memory changes pre- to post-tES

时间窗: 1 year

Observe effects of each tES condition within each of the 5 sessions on the N-back memory task

次要结局

  • Rate of side effects from tES(1 year)

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