Transcranial Direct Current Stimulation for Improving Gait Training in Stroke
2018年11月26日 更新者:University of Arkansas
Using Transcranial Direct Current Stimulation to Jump Start Gait Training in Chronic Stroke Patients
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with assisted gait training is effective for improving gait in patients with chronic stroke.
研究概览
研究类型
介入性
注册 (实际的)
6
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Conway、Arkansas、美国、72035
- University of Central Arkansas
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Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Stroke survivors > 3 months from most recent unilateral, stroke based on clinically or experimentally obtained MRI brain scans and behavioral evidence of stroke (e.g., risk factors, hemiplegia, unilateral sensory impairment, or localized higher cortical dysfunction) by report or in the medical record.
- Age: >21 years of age.
- Complete NIH Stroke Scale.
- Sufficient endurance, motor ability and balance to ambulate at least 10 meters continuously with moderate or less assistance.
- Demonstrate gait impairment during ambulation such that gait instability or inefficient gait patterns [gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes] are exhibited.
- Pass the Transcranial Magnetic Stimulation (TMS) Adult Safety Screen (TASS) except for items related specifically to stroke and the treatment for stroke.
Exclusion Criteria:
- Edema, skin breakdown, absent sensation of the affected lower limb which interferes with the peroneal nerve stimulator.
- History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability.
- Demand pacemakers or any other implanted electronic systems.
- Pregnant women, uncontrolled seizure disorder, Parkinson's Disease, Spinal cord injury, Traumatic brain injury with evidence of motor weakness, Multiple sclerosis.
- Documented episode in the medical record of a seizure occurring 1 month or more post stroke for which the patient received consultation or treatment for said seizures. Seizures occurring within the first month following a stroke are not exclusionary unless followed by another seizure.
- Fixed ankle plantar flexor contracture, peroneal nerve injury at the fibular head as the cause of foot-drop.
- History of dementia, severely impaired cognition, communication or comprehension deficits.
- Presence of severe or frequent headaches
- History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry.
- Have other medical conditions or are taking medications that compromise ambulation or balance.
- Failure to meet established screening criteria for TMS or tDCS (i.e., TASS)
- Principal Investigator's or Medical Monitor's discretion not to include a participant.
Additional Exclusion Criteria for MRI Scan
- Claustrophobia, or the inability to lie still in a confined space
- Major medical disorders (e.g., HIV, cancer)
- Medications which may affect image quality (e.g., water pills)
- Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents), as these may heat, pull, or twist in the strong magnetic field of the MRI scanner
- Non-removable dental implants, such as braces or permanent retainers, as these will distort the MRI images we collect (note: filings, crowns, and silver or gold teeth are OK)
- Permanent makeup or tattoos with metallic dyes
- A positive pregnancy test (for females), since the effect of strong magnetic fields on the developing fetus remains unknown and inconclusive. (We will conduct a pregnancy test for all female participants on the day of the MRI scan.)
- Psychotic disorders (e.g., schizophrenia)
- Any other condition that the investigator believes might put the participant at risk
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:transcranial direct current stim
tDCS will be applied using a Soterix constant current stimulator with 5 x 5 cm (25cm2) carbon rubber electrodes (Covidien 664 REFX 2x2) applied to the scalp with 10-20 conductive paste.
The anodal electrode will be placed over the lower extremity representation of primary motor cortex of the lesioned hemisphere [established during TMS motor threshold testing (Baseline Testing) and the functional MRI assessment].
The cathodal electrode will be placed over the contralateral motor cortex.
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During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
During sham stimulation the stimulator is turned off.
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安慰剂比较:sham tDCS
Sham stimulation will be performed by turning the stimulator off after the initial sensory experience (30 seconds).
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During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down).
During sham stimulation the stimulator is turned off.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait
大体时间:Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
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Over ground laboratory assessments of gait: 1) Gait velocity and spatiotemporal gait parameters will be measured with the GAITRite system (CIR Systems, Inc., Havertown, PA) 28-35.
2) Hip, ankle, and knee angles during gait will be measured using the Simi Aktisys gait analysis system (Simi Reality Motion Systems; Postfach, Unterschleissheim Germany).
LED markers are placed on the participant's lower extremity.
Ankle, knee, and hip angle data is obtained simultaneously to evaluate motor strategies for overcoming gait impairments.
Both types of data will be collected simultaneously as participants walk 10 meters across the GAITRite walkway at a self-selected speed for 5 repetitions.
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Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).
大体时间:Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
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A Magstim 200 super rapid2 stimulator with a 110 mm double cone coil will deliver stimulation.
First, the TMS motor threshold (MT) will be established and the best location for eliciting MEPs from the contralesional and ipsilesional TA muscle will be tracked on the subject's MRI scan in Brainsight.
Recruitment curves will be obtained as follows: 1) delivering ten, single TMS pulses beginning at 70% of MT, 2) increasing TMS intensity by 10% and repeating the process up to 160% of the MT or until a plateau in the recruitment curve is reached, 3) offline data processing will be performed with the Matlab curve fitting toolbox and 4) the threshold, slope, and MEPmax, and the goodness of fit (R2) will be calculated.
A change in the slope of the recruitment curve will indicate change in cortical excitability.
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Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
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Change From Baseline in Stroke Impact Scale Scores
大体时间:Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
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The Stroke Impact Scale-16 (SIS-16, completed by study team) is a standardized instrument 36-38 that assesses 3 functional domains in stroke patients including ADL / IADL, mobility, and social and occupational engagement.
It consists of 64 - 5 point likert scale questions with a total score range of 64(lowest) to 320 (highest).
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Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年3月1日
初级完成 (实际的)
2017年11月17日
研究完成 (实际的)
2017年11月17日
研究注册日期
首次提交
2013年3月6日
首先提交符合 QC 标准的
2013年3月6日
首次发布 (估计)
2013年3月8日
研究记录更新
最后更新发布 (实际的)
2018年12月11日
上次提交的符合 QC 标准的更新
2018年11月26日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.