kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery
研究概览
详细说明
The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.
After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ludovica Labruna, PhD
- 电话号码：5104237125
- 邮箱：participate@magnetictides.com
学习地点
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California
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San Francisco、California、美国、94158
- 招聘中
- UCSF Mission Bay- Sandler Neurosciences Center
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接触：
- Christina Merrick
- 电话号码：510-423-7125
- 邮箱：participate@magnetictides.com
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首席研究员：
- Ludovica Labruna, PhD
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首席研究员：
- Richard Ivry, PhD
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首席研究员：
- Karunesh Ganguly, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria:
- Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Exclusion criteria:
- Participants with moderate or severe cognitive impairment (MoCA < 18).
- Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
- Participants with severe apraxia (TULIA < 5).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- Absolute contraindications related to non-invasive brain stimulation, including:
9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：主动KTMP
参与者接受了8 v/m的主动刺激
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一种新型非侵入性脑刺激工具
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假比较器：Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
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一种新的非侵入性脑刺激工具，选择了假设置
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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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Range of Joint Motion (ROM)
大体时间：6 weeks
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defined as the standard deviation of the joint angle time series for a given trial.
The median ROM will be calculated for eleven degrees of freedom and then averaged.
If there are joints which appear to be compensatory, they will be removed from the analysis
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6 weeks
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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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Fugl- Meyer Assessment (Upper Extremity)
大体时间：6 weeks
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A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment.
It is graded from 0 (hemiplegia) to 66 for the Upper extremity.
Higher scores signifies better motor control, and hence a better outcome.
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6 weeks
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Modified Ashworth Scale (MAS)
大体时间：6 weeks
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Used to measure spasticity in wrist and hand flexors and extensors.
It assigns a grade of spasticity from 0-4.
Lower scores represent normal muscle tone and higher scores represent spasticity.
Hence lower scores are associated with better outcomes.
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6 weeks
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Transport Time
大体时间：6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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Trial to Trial Variability (T2TV)
大体时间：6 weeks
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Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries.
The median T2TV will be calculated for eleven degrees of freedom.
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6 weeks
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Grasp to Lift Time
大体时间：6 weeks
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Calculated for each of three epochs, pre, during and post
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6 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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