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临床试验/NCT04759898
NCT04759898已完成不适用

Direct Measurement of Motor Cortical Responses to Transcranial Direct Current Stimulation

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in primary motor cortical (PriMC) beta oscillations during cued arm reaching in relation to anodal tDCS activation

研究概览

简要总结

Transcranial direct current stimulation (tDCS) has shown the potential to improve symptoms in patients with movement deficits, such as Parkinson's disease and chronic stroke. However, the effects of tDCS have so far not been proven on a wider scale due to lack of knowledge regarding exactly how tDCS works. This has limited the adoption of this potentially useful therapy for patients with Parkinson's disease, chronic stroke and other conditions affecting movement. The investigators hypothesize that by studying the effects of tDCS in subjects performing a motor task, the brain signals mediating improvements in motor control will be identified. The investigators will use both noninvasive and invasive methods to explore this hypothesis. The investigators expect this combined approach to broaden understanding of tDCS application in conditions affecting movement and possibly lead to therapeutic advances in these populations.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

盲法说明

In the first and second arms, prior to placement of electrodes, subjects will be randomized to either treatment or sham. This will occur using a random number generator with a binary choice determination (1 = stimulation; 2 = sham). Patients will be blinded to this choice.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 or older
  • Previous consent to be contacted regarding potential participation in a research study at Medical University of South Carolina

排除标准

  • Subjects unable to actively participate in the consent process physically and/or cognitively
  • Pregnancy
  • Presence of scalp injury or disease
  • Prior history of seizures
  • Metal implants in head or neck
  • Prior intracranial surgery
  • Prior brain radiotherapy
  • Prior history of intracranial tumor, intracranial infection or cerebrovascular malformation

研究组 & 干预措施

Stimulation (invasive recording)

Patients with Parkinson's disease undergoing surgery for deep brain stimulation will be studied using electrocorticography combined with transcranial direct current stimulation

干预措施: transcranial direct current stimulation (invasive recording) (Device)

结局指标

主要结局

Change in primary motor cortical (PriMC) beta oscillations during cued arm reaching in relation to anodal tDCS activation

时间窗: Subjects will undergo baseline EEG recording 5 min before tDCS starts, during tDCS (5 min after stimulation starts) and 5 min after tDCS stimulation ends. Measurements will be made similarly during sham stimulation.

EEG is used to track beta spectral power during a cued motor task in conjuction with transcranial direct current stimulation or sham

Change in primary motor cortical (PriMC) beta oscillations during arm flexion in relation to anodal tDCS activation

时间窗: Subjects will undergo baseline ECoG recording 5 min before tDCS starts, during tDCS (5 min after stimulation starts) and 5 min after tDCS stimulation ends. Measurements will be made similarly during sham stimulation.

ECoG is used to track beta spectral power during an arm flexion task in conjuction with transcranial direct current stimulation

Change in Primary Motor Cortex Beta-Band Spectral Power During Movement Preparation With Anodal tDCS

时间窗: Intraoperative assessment during deep brain stimulation surgery: baseline (pre-tDCS) and during anodal tDCS; change from baseline during movement preparation reported.

Primary motor cortex (PriMC) beta-band (13-30 Hz) spectral power was measured using subdural electrocorticography (sECoG) in patients with Parkinson's disease undergoing deep brain stimulation surgery. Spectral power was analyzed during the movement preparation phase of a cued arm-reaching task. The outcome represents the change in beta-band spectral power during anodal transcranial direct current stimulation (tDCS) relative to pre-stimulation baseline, averaged across task trials for each participant.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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