The Effect Of Sham Controlled Continuous Theta Burst Stimulation And Low Frequency Repetitive Transcranial Magnetic Stimulation On Upper Extremity Spasticity And Functional Recovery In Patients With Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Upper Extremity Fugl-Meyer Motor Function Scale
研究概览
简要总结
This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.
详细描述
A sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rTMS group (n=7), active cTBS group (n=7) and sham cTBS group (n=6). In the active rTMS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In the active cTBS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. Sham cTBS was applied in the same protocol but using sham coil. Within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. Upper Extremity Fugl-Meyer Motor Function Scale, Modified Ashworth Scale (MAS), Functional Independence Measure (FIM), Motor Activity Log-28 (MAL-28) and Brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.
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
- Triple (Participant, Care Provider, 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
- •ischemic stroke with a disease interval of 6 months to 2 years
- •aged between 18-80 years
- •Mini mental test score ≥ 24
- •upper limb Brunnstrom recovery stage 3 to 5
- •upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS) 1+ to 3
排除标准
- •hemorrhagic stroke
- •history of epilepsy
- •a cardiac pacemaker
- •pregnancy
- •history of previous stroke or ischemic attack
- •neurological diseases other than stroke
- •metallic implant in brain or scalp (including cochlear implant)
- •previous brain surgery
- •orthopedic disease that prevents upper extremity movements
- •poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.)
- •diagnosis of malignancy
- •injections of botulinum toxin in the last 6 months for the affected upper extremity
- •drug or dosage changes of anti-spasticity medications in the last 1 month period
结局指标
主要结局
Upper Extremity Fugl-Meyer Motor Function Scale
时间窗: up to 6 weeks
Scale measures level of upper extremity motor functions (min-max: 18-126 points). Higher values represent a better outcome.
Modified Ashworth Scale
时间窗: up to 6 weeks
Scale measures muscle tone (spasticity) (min-max:0-4). Higher values represent a worse outcome.
次要结局
- Motor Activity Log-28(up to 6 weeks)
- Brunnstrom Motor Recovery Scale(up to 6 weeks)
- Functional Independence Measure(up to 6 weeks)
研究者
Yasin Demir
Clinical Associate Professor
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital