Transcranial magneticstimulation for enhancing recovery of function after acute stroke.(TRYST)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in FMA-UE(Fugl Meyer Assessment-Upper extremity) score
研究概览
简要总结
Background: Patients with acutestroke have limb weakness and spasticity,affecting normal functioning. Limited recovery from stroke may be partly caused by imbalanced interaction between thecerebral hemispheres, with reducedexcitability of the ipsilesional motor cortex whileexcitability of the contralesional motor cortex is increased. Non- invasive brain stimulation with repetitive transcranialmagnetic stimulation (rTMS) may aid inrelieving a post- stroke interhemispheric excitabilityimbalance, which could improve functional recovery. While there are encouraging studies in patients with chronicstroke, the evidence of rTMS efficacy in motor recovery and alleviation ofspasticity is lacking in the setting of acute stroke.
Methods and Objectives: An InterventionalDouble Blinded Randomized Study of 60subjects presenting with acute stroke (3-15days from onset) will be studied. The effects of ipsilesional primary motor cortex(M1) and DLPFC at 5Hz, withcontralesional M1 at 1Hz will be studied.Subjects will receive 10 sessions of rTMS over two weeks for two consecutive months, apart from routinephysical therapy.
The primary outcomewill be explored on a superiority analysis basis, by comparison of mean increase in FMA -UE (Fugl MeyerAssessment– upper extremity) scores from baseline to 3 months between theintervention and sham group stroke patients,Secondary outcome parameters including ARAT, MRS, SSQoL,BDI etc. will be assessed at predefinedintervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •First episode of acute hemispheric stroke (infarct or bleed) as established on neuroimaging
- •Day 3 – 15 from onset of stroke symptoms,
- •NIH arm motor score >1
- •Stable GCS greater than or equal to 8 and off ventilator for 48 hours.
排除标准
- •1 Patients with major cognitive deficits/spasticity / contracture/limb deformities interfering with study participation.
- •Epilepsy, psychosis, delirium.
- •Patients who received Intravenous or Intra-arterial tissue plasminogen activator or thrombectomy
- •Concomitant acute Myocardial Infarction, pulmonary embolism or Deep Venous Thrombosis
- •Hemodynamic instability
- •Major cardiac, renal, hepatic or pulmonary dysfunction
- •Uncontrolled sepsis
- •Trauma-orthopedic injury that limits the range of motion of the upper limb
- •Contraindications to TMS like intracranial metallic implants, cardiac implants, pacemakers
- •Pregnancy or likely to become pregnant during the study period.
- •Premorbid MRS score- greater than 2
- •Not willing to consent.
结局指标
主要结局
Improvement in FMA-UE(Fugl Meyer Assessment-Upper extremity) score
时间窗: 3 months
次要结局
- MAS (modified ashworth score), ARAT (action research arm test) and MRS (modified rankin scores)(3 months)