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临床试验/NCT02465034
NCT02465034终止不适用

Noninvasive Brain Stimulation to Evaluate Neural Plasticity After Stroke

Emory University4 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
45
试验地点
4
主要终点
Change in Long-term Potentiation-like Plasticity

研究概览

简要总结

The purpose of this study is to examine how different areas in the brain interact with each other and how using brain imaging and brain stimulation approaches can influence these interactions.

详细描述

Subcortical strokes affect small vessels deep in the brain, and typically present with motor hemiparesis. The investigator will assess the effects of Transcranial Magnetic Stimulation (TMS) on motor function and examine how different areas in the human brain interact with each other using brain imaging and brain stimulation. The investigator will also evaluate the capacity for noninvasive stimulation to transiently modify brain activity supporting arm movement.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18-85 years
  • Middle cerebral artery stroke
  • Individuals with a first time stroke that affects the corona radiata and/or internal capsule

排除标准

  • Age outside the age range of 18-85 years
  • Signs of dementia (score < 24 on the Montreal Cognitive Assessment)
  • Aphasia (score < 13 on the Frenchay Aphasia Screen)
  • History of head trauma
  • History of a major psychiatric diagnosis
  • History of a neurodegenerative disorder
  • History of substance abuse
  • Contraindications to Transcranial Magnetic Stimulation

结局指标

主要结局

Change in Long-term Potentiation-like Plasticity

时间窗: Baseline, 1 Minute Post-Paired Associative Stimulation

Long-term potentiation-like plasticity was measured using paired associative stimulation (PAS). PAS consists of repeated peripheral electric stimulation paired with Transcranial Magnetic Stimulation (TMS) applied to the motor cortex at varying interstimulus intervals. Participants received 180 paired stimuli at 0.25 hertz (Hz) for 12 minutes. Impaired long-term potentiation-like plasticity points towards reduced excitatory synaptic connectivity and deficits in sensorimotor integration. Decrease or no change in the amplitudes of motor-evoked potentials (MEPs) indicates impaired long-term potentiation-like plasticity.

Electroencephalography Recordings at Baseline and 5 MInutes Post-PAS

时间窗: Baseline, 5 Minutes Post-Paired Associative Stimulation

Electroencephalography (EEG) data were recorded using a 64-channel TMS-compatible electrode cap (Easy Cap). Signals were collected at 2000 hertz (Hz) during pre- and post-transcranial magnetic stimulation epochs (-100ms to 200ms). Up to fifty suprathreshold (120% AMT) transcranial magnetic stimulation pulses were applied to motor cortex while the subject was seated quietly with eyes open. This procedure was conducted bilaterally. Data epochs (-1000 to 4000 ms with respect to TMS delivery) were extracted for subsequent imaginary phase coherence analysis. Post-TMS coherence values between electrodes overlying M1 bilaterally (C3 and C4) were calculated within the beta frequency range (15 to 30 Hz). EEG data values are unit-free that can range from 0 to 1. Higher values represent greater coherence which is thought to indicate stronger connectivity.

Abbreviated Wolf Motor Function Test Time

时间窗: Baseline, 10 Minutes Post-Paired Associative Stimulation

Three items of the Wolf Motor Function Test (WMFT) were used to evaluate functional motor performance. The 3 items were selected based on task difficulty ranging from easiest (hand to table) to most difficult (stack checkers) along with a task of moderate difficulty (lift can). Each task has different control demands and number of actions required to complete successfully. Task performance is timed in seconds, with a maximum time of 120 seconds.

次要结局

  • Wolf Motor Function Test(Baseline)
  • Abbreviated Wolf Motor Function Test Time(30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation)
  • Electroencephalography Recordings at 30 Minutes and 24 Hours Post-PAS(30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation)
  • Serial Reaction Time Task (SRTT) Performance(Baseline, 10 minutes post-PAS, 30 minutes post-PAS, and 24 hours post-PAS)
  • Long-term Potentiation-like Plasticity(30 minutes post-Paired Associative Stimulation, 24 hours post-Paired Associative Stimulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael R Borich

Associate Professor

Emory University

研究点 (4)

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