Electroencephalogram Coupled Non-invasive Brain Stimulation For Assessment of Cortical Excitability
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Change in Modified Rankin Scale
研究概览
简要总结
This research study is being done to look at the safety and diagnostic benefit of conducting an TMS(transcranial magnetic stimulation)-EEG measured before and after a brief experimental stimulation session using investigational devices repetitive TMS or transcranial direct current stimulation (tDCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.
- •Inclusion Criteria - Healthy Controls:
- •- No known active neurological disorder.
排除标准
- •Pregnancy
- •Contraindication to MRI or TMS including metallic implanted objects.
- •Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
- •Severe aphasia.
- •History of epilepsy.
- •History of active depression or treatment resistant depression.
- •History of schizophrenia.
- •Exclusion Criteria - Healthy Controls:
- •Pregnancy
- •Contraindication to MRI or TMS including metallic implanted objects.
- •History of acquired brain injury.
研究组 & 干预措施
Non-Stroke Subjects
Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
干预措施: Electroencephalogram (Diagnostic Test)
Non-Stroke Subjects
Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
干预措施: Transcranial Magnetic Stimulation (Procedure)
Non-Stroke Subjects
Subjects will receive up to 30 minutes of focal simulation with either TMS or tDCS administered to one brain location within standard safety protocols
干预措施: Transcranial Direct Current Stimulation (Procedure)
Stroke Subjects
Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
干预措施: Electroencephalogram (Diagnostic Test)
Stroke Subjects
Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
干预措施: Transcranial Magnetic Stimulation (Procedure)
Stroke Subjects
Subjects will receive up to 30 minutes of focal stimulation with either TMS or tDCS administered to one brain location within standard safety protocols
干预措施: Transcranial Direct Current Stimulation (Procedure)
结局指标
主要结局
Change in Modified Rankin Scale
时间窗: Baseline, 3 months
Measured using the Modified Rankin Scale (MRS) to assess functional outcome measure in stroke that utilizes a structured interview to assign subjects MRS grades 0-5 in a systematic way, grade 5 is severe disability, grade 0 is no symptoms at all
EEG and TMS-EEG functional connectivity
时间窗: Baseline
EEG power in high and low frequency bands will be measured and power density maps will be created. TMS-evoked potentials and oscillations will be measured.
MRI based structural connectivity.
时间窗: Baseline
Microstructural integrity of the networks will be quantified by using diffusion weighted imaging metrics such as mean diffusivity.
Change in Western Aphasia Battery (WAB) Aphasia (AQ) and Language Quotients (LQ)
时间窗: Baseline, 3 months
Measured using Western Aphasia Battery Bedside Version. Higher score is better. Ranged from 0-100.
Change in neurological outcome (NIHSS)
时间窗: Baseline, 3 months
Measured using the National Institutes of Health Stroke Scale (NIHSS). 15-item test to assess stroke-related neurologic deficits, each item scored with 3-5 grades with 0 as normal.
次要结局
未报告次要终点