Effects of Different Theta Burst Stimulation Protocols Combined With Conventional Rehabilitation on Upper and Lower Extremity Motor Recovery in Patients With Early-Stage Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
研究概览
简要总结
This single-center, single-blind, randomized, sham-controlled clinical trial will include 60 patients aged >45 years who are within 3 months of a first-ever middle cerebral artery ischemic stroke. Participants will be randomized into four groups: coupled TBS (contralesional cTBS followed by ipsilesional iTBS), cTBS plus sham iTBS, sham cTBS plus iTBS, or sham TBS. TBS will be delivered over the primary motor cortex for 10 sessions over 2 weeks. Stimulation intensity will be set at 80% of the resting motor threshold determined using EMG-guided motor evoked potentials. Each cTBS and iTBS application will consist of 600 pulses. All participants will additionally receive standardized conventional rehabilitation for at least 4 weeks.
The primary outcome will be upper-extremity motor recovery assessed using the motor domain of the Fugl-Meyer Assessment. Secondary outcomes will include lower-extremity motor recovery, spasticity, sensory function, cortical excitability, functional ambulation, activities of daily living, and stroke-specific quality of life. Assessments will be performed at baseline, after the 2-week intervention, and at 1-month post-treatment follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants and the TMS operator administering the stimulation will be blinded to group allocation. Sham stimulation will be delivered using a sham coil designed to mimic the corresponding active TBS procedures, thereby maintaining blinding of both participants and the TMS operator throughout the intervention.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ischemic stroke due to middle cerebral artery (MCA) occlusion confirmed by magnetic resonance imaging (MRI).
- •Within the first 3 months after stroke.
- •First-ever stroke.
- •Age ≥45 years.
- •Brunnstrom stage 1, 2, or 3 for the upper extremity and hand.
- •No previous physical therapy after the current stroke.
- •Ability to maintain at least minimal semi-sitting balance.
- •Medically and neurologically stable.
- •Mini-Mental State Examination score >
- •Native Turkish speaker who voluntarily agrees to participate and provides written informed consent.
排除标准
- •History of epilepsy.
- •Presence of a pacemaker.
- •Pregnancy.
- •Neurological disease other than stroke.
- •Metallic implants in the brain or scalp, including cochlear implants.
- •History of brain surgery.
- •Comorbid disease that may significantly impair general health, such as heart f-failure or chronic obstructive pulmonary disease, and/or severe infection.
- •Diagnosis of malignancy.
- •Peripheral nerve injury and/or musculoskeletal disorder affecting motor function of the upper or lower extremities, such as fracture.
- •Cardiac arrhythmia.
- •Aphasia, spatial neglect, or visual field loss.
- •Visual or hearing impairment that prevents communication.
- •Alcohol and/or drug dependence.
- •Refusal to participate or failure to provide informed consent.
研究组 & 干预措施
Sham cTBS + iTBS Group
Participants will receive contralesional sham continuous theta burst stimulation (sham cTBS) followed by ipsilesional intermittent theta burst stimulation (iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Sham Continuous Theta Burst Stimulation (Device)
Coupled TBS Group
Participants will receive contralesional continuous theta burst stimulation (cTBS) followed by ipsilesional intermittent theta burst stimulation (iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Continuous Theta Burst Stimulation (cTBS) (Device)
Coupled TBS Group
Participants will receive contralesional continuous theta burst stimulation (cTBS) followed by ipsilesional intermittent theta burst stimulation (iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Intermittent Theta Burst Stimulation (iTBS) (Device)
cTBS + Sham iTBS Group
Participants will receive contralesional continuous theta burst stimulation (cTBS) followed by ipsilesional sham intermittent theta burst stimulation (sham iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Continuous Theta Burst Stimulation (cTBS) (Device)
cTBS + Sham iTBS Group
Participants will receive contralesional continuous theta burst stimulation (cTBS) followed by ipsilesional sham intermittent theta burst stimulation (sham iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Sham Intermittent Theta Burst Stimulation (Device)
Sham cTBS + iTBS Group
Participants will receive contralesional sham continuous theta burst stimulation (sham cTBS) followed by ipsilesional intermittent theta burst stimulation (iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Intermittent Theta Burst Stimulation (iTBS) (Device)
Sham TBS Group
Participants will receive contralesional sham continuous theta burst stimulation (sham cTBS) followed by ipsilesional sham intermittent theta burst stimulation (sham iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Sham Continuous Theta Burst Stimulation (Device)
Sham TBS Group
Participants will receive contralesional sham continuous theta burst stimulation (sham cTBS) followed by ipsilesional sham intermittent theta burst stimulation (sham iTBS) within the same session. Ten sessions will be administered over 2 weeks in addition to standardized conventional rehabilitation.
干预措施: Sham Intermittent Theta Burst Stimulation (Device)
结局指标
主要结局
Change in Upper Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Upper Extremity Motor Subscale (FMA-UE)
时间窗: Baseline, Week 2, and Week 6
Upper extremity motor function will be assessed using the motor subsection of the Fugl-Meyer Assessment. The FMA-UE motor score ranges from 0 to 66, with higher scores indicating better upper extremity motor function. Each item is scored on a 3-point ordinal scale: 0 = cannot perform, 1 = performs partially, and 2 = performs fully
Change in Lower Extremity Motor Function Assessed by the Fugl-Meyer Assessment - Lower Extremity Motor Subscale
时间窗: Baseline, Week 2, and Week 6
Lower extremity motor recovery will be assessed using the lower extremity motor subsection of the Fugl-Meyer Assessment.
Change in Motor Recovery Stage Assessed by the Brunnstrom Motor Recovery Stages
时间窗: Baseline, Week 2, and Week 6
Motor recovery of the upper and lower extremities will be evaluated using the Brunnstrom Motor Recovery Stages. Each assessed region is rated separately from stage I (1) to stage VI (6), with higher stages indicating better motor recovery.
次要结局
- Change in Spasticity Assessed by the Modified Ashworth Scale(Baseline, Week 2, and Week 6)
- Change in Sensory Function Assessed by the Fugl-Meyer Assessment - Sensory Subscale(Baseline, Week 2, and Week 6)
- Change in Cortical Excitability Assessed by Motor Evoked Potential Amplitude(Baseline, Week 2, and Week 6)
- Change in Cortical Excitability Assessed by Motor Evoked Potential Latency(Baseline, Week 2, and Week 6)
- Change in Functional Ambulation Assessed by the Functional Ambulation Scale(Baseline, Week 2, and Week 6)
- Change in Independence in Activities of Daily Living Assessed by the Modified Barthel Index(Baseline, Week 2, and Week 6)
- Change in Stroke-Specific Quality of Life(Baseline, Week 2, and Week 6)
研究者
Ayse Naz Kalem
pm&r specialist
Ankara Etlik City Hospital