TMS AND BOTULINUM TOXIN IN POST-STROKE UPPER LIMB SPASTICITY (TMS)
2026年5月29日 更新者：Asya ÖZCAN KAVCI
COMPARISON OF CLINICAL OUTCOMES ASSOCIATED WITH DIFFERENT TRANSCRANIAL MAGNETIC STIMULATION PROTOCOLS COMBINED WITH BOTULINUM TOXIN-A INJECTION IN POST-STROKE UPPER LIMB SPASTICITY
Post-stroke upper limb spasticity is an important condition that negatively affects motor recovery, upper limb functions, and activities of daily living.
Multimodal treatment approaches are recommended in the management of spasticity.
In recent years, the effects of transcranial magnetic stimulation (TMS) on upper limb functions and spasticity have been investigated.
However, the clinical effects of different TMS protocols combined with botulinum toxin-A (BTX-A) treatment and which protocol may be more effective remain unclear.
The aim of this observational study is to compare the clinical effects of different TMS protocols in patients with post-stroke upper limb spasticity receiving BTX-A treatment and to evaluate the most appropriate TMS protocol.
研究概览
地位
完全的
条件
详细说明
As part of the study, patients who received botulinum toxin type A (BTX-A) injections for upper extremity spasticity following stroke were evaluated using different TMS protocols.
All patients received a standard conventional physical therapy program.
TMS sessions were conducted using an inhibitory protocol, with a total of 10 sessions administered to the contralateral hemisphere at least 3 days per week.
Clinical evaluations were performed at baseline, at 1 month, and at 3 months.
Thus, the early and long-term clinical outcomes of treatment were investigated.
Spasticity was assessed using the Modified Ashworth Scale (MAS), motor improvement using the Brunnstrom staging system, upper extremity motor function using the Fugl-Meyer Assessment, and upper extremity use in activities of daily living using the Motor Activity Log-28 (MAL-28).
Additionally, patients' anxiety and depression levels were measured using the Hospital Anxiety and Depression Scale (HADS).
研究类型
介入性
注册 (实际的)
39
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
-
-
Ankara
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Ankara、Ankara、土耳其（türkiye）、06010
- Ankara Etlik City Hospital, Physical Medicine and Rehabilitation Clinic
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Diagnosis of stroke (ischemic or hemorrhagic)
- Time since stroke onset between 3 and 24 months
- Age between 18 and 80 years
- Upper extremity motor recovery at Brunnstrom Stages 3-5
- Spasticity in the elbow, wrist, or finger flexor muscle groups of the upper extremity with a Modified Ashworth Scale (MAS) score between +1 and 3
- Receipt of botulinum toxin-A injection to the affected upper extremity within the previous week
Exclusion Criteria:
- History of epileptic seizures, epileptiform EEG findings, increased seizure risk, or use of antiepileptic medication
- Presence of implanted metallic or electronic devices (e.g., cardiac pacemaker, intrathecal baclofen pump)
- Pregnancy or lactation
- Presence of neurological disorders other than stroke
- History of cranial surgery
- Orthopedic conditions or previous orthopedic surgery limiting upper extremity movement
- Severe upper extremity spasticity (MAS >3) or presence of contracture
- Uncontrolled hypertension, advanced heart failure (NYHA Class III-IV), chronic obstructive pulmonary disease (COPD), active infection, severe hepatic failure, or severe renal failure
- History of malignancy
- Severe cognitive impairment (Mini-Mental State Examination score <24)
- Severe aphasia or communication disorder that would interfere with participation in the study
- Botulinum toxin injection administered to the upper extremity in a separate treatment session within the previous 3 months
- Any change in medication type or dosage within the previous month for oral medications used in the management of spasticity
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 |
|---|---|
|
实验性的：rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and repetitive transcranial magnetic stimulation (rTMS) using an inhibitory stimulation protocol.
|
Repetitive transcranial magnetic stimulation (rTMS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol.
Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
|
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假比较器：Sham rTMS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and sham repetitive transcranial magnetic stimulation (sham rTMS).
The sham procedure was designed to mimic active stimulation without delivering therapeutic stimulation.
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Sham repetitive transcranial magnetic stimulation (sham rTMS) was administered using procedures designed to mimic active stimulation without delivering therapeutic magnetic stimulation.
Treatment was provided in combination with botulinum toxin-A injections and conventional physical therapy.
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实验性的：cTBS Group
Participants received botulinum toxin-A treatment, conventional physical therapy, and continuous theta burst stimulation (cTBS) using an inhibitory stimulation protocol.
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Continuous theta burst stimulation (cTBS) was applied to the contralateral hemisphere using an inhibitory stimulation protocol.
Treatment was administered in 10 sessions, at least 3 days per week, in combination with botulinum toxin-A injections and conventional physical therapy.
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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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Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
大体时间：Baseline, 1 Month, and 3 Months
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Spasticity severity was assessed using the Modified Ashworth Scale.
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Baseline, 1 Month, and 3 Months
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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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Change in Motor Recovery Assessed by Brunnstrom Staging
大体时间：Baseline, 1 Month, and 3 Months
|
Motor recovery of the upper extremity and hand was assessed using Brunnstrom staging.
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Baseline, 1 Month, and 3 Months
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Change in Upper Extremity Motor Function Assessed by Fugl-Meyer Assessment
大体时间：Baseline, 1 Month, and 3 Months
|
Upper extremity motor function was assessed using the Fugl-Meyer Assessment.
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Baseline, 1 Month, and 3 Months
|
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Change in Upper Extremity Use Assessed by Motor Activity Log-28
大体时间：Baseline, 1 Month, and 3 Months
|
The frequency and quality of upper extremity use in daily activities were assessed using the Motor Activity Log-28.
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Baseline, 1 Month, and 3 Months
|
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Change in Anxiety and Depression Levels Assessed by Hospital Anxiety and Depression Scale
大体时间：Baseline, 1 Month, and 3 Months
|
Anxiety and depression levels were assessed using the Hospital Anxiety and Depression Scale.
|
Baseline, 1 Month, and 3 Months
|
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。
调查人员
- 首席研究员：Damla CANKURTARAN, Associate Professor, MD、Ankara Etlik City Hospital, Department of Physical Medicine and Rehabilitation
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)
2025年1月20日
初级完成 (实际的)
2026年5月26日
研究完成 (实际的)
2026年5月26日
研究注册日期
首次提交
2026年5月29日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月3日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年5月29日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- SBU-FTR-AOK-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared due to privacy and confidentiality considerations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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