COMPARISON OF CLINICAL OUTCOMES ASSOCIATED WITH DIFFERENT TRANSCRANIAL MAGNETIC STIMULATION PROTOCOLS COMBINED WITH BOTULINUM TOXIN-A INJECTION IN POST-STROKE UPPER LIMB SPASTICITY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Asya ÖZCAN KAVCI
MD, Resident Physician
Ankara Etlik City Hospital