Comparison of Two Deep TMS Protocols With Paired Associative Stimulation (PAS) for the Treatment of Motor Impairement in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score
研究概览
简要总结
Paired associative stimulation (PAS) delivered with multi-channel deep transcranial magnetic stimulation (dTMS) may enhance motor recovery in patients with first-ever ischemic stroke. This study evaluates whether dTMS-PAS targeting both primary motor cortices (M1-M1) improves upper-extremity hemiparesis when administered at the early subacute stage (up to three weeks poststroke).
详细描述
Unilateral ischemic stroke disrupts the activity balance between the hemispheres, which hinder brains' recovery and treatments' efficiency. The most common and pervasive acquired postischemic stroke functional disorder is hemiparesis of the upper-extremity. The limited impact of conventional rehabilitation therapies is attributed to their inability to restore the interhemispheric balance. Thus, PAS protocol, delivered using dTMS, may benefit patients by regaining the interhemispheric balance. PAS is delivered over two different cortical brain areas, and the modulation of interhemispheric balance is determined by which area is stimulated by the first pulse and which by the second. In this study, the investigators apply a dTMS-PAS protocol over the two primary motor cortices, to restore the activity balance between M1-M1, alleviate upper-extremity hemiparesis symptoms, and promote functional recovery.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis of stroke is based on computed tomography (CT) or magnetic resonance imaging (MRI).
- •The diagnosis of first acute ischemic stroke in unilateral hemisphere within 3 weeks after onset.
- •Clinically evident arm hemiparesis attributable to acute ischemic stroke.
- •Age of 18-85 years.
- •The ability to sign a informed consent.
排除标准
- •Any previous stroke.
- •Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
- •Prior participation in the present study, or planned participation in another therapeutic trial, prior to the final assessment in this trial.
- •Current participation in another study with an investigational drug or device.
- •Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
- •Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months prior to participation in the current study.
- •Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation.
- •Intracranial aneurysm, unless surgically or endovascularlytreated more than 3 months prior to participation in the current study.
- •Seizure at the onset of stroke or a history of epilepsy.
- •Life expectancy less than 3 months.
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- •Other serious illness, e.g., severe hepatic, cardiac, or renal failure.
- •Acute myocardial infarction or complex disease that may confound treatment assessment.
- •Cognitive or verbal impairment that prevented understanding of or cooperation with the research study.
- •Under the following medical conditions, treatment was stopped, and patients were excluded from the study:
- •Acute worsening of > 4 points on the NIH stroke scale (NIHSS).
- •Acute symptoms of headache nausea and vomiting suggestive of possible sICH.
- •Occurrence of seizures.
- •Appearance of a new ventricular arrhythmia, tachycardia, fibrillation etc. or a new life-threatening supraventricular arrhythmia (e.g., rapid atrial fibrillation or supraventricular tachycardia).
- •Symptomatic bradycardia - heart rate less than 50 beats per min.
结局指标
主要结局
Fugl - Meyer Assessment for Upper Extremity (FMA-UE) Score
时间窗: From enrollment to one year after enrollment
The FMA-UE is a standardized, clinical, stroke-specific performance scale assessing motor impairement of the upper-extremity. It includes 33 items across four domains (shoulder-arm, wrist, hand, coordination), each scored 0-2 (total range 0-66). Higher scores indicate better motor function. Assessment Schedule: Pre-treatment (up to three weeks poststroke), Post-treatment (three weeks consisting of 15 sessions), 1 and 2 months post-treatment, and 6,9, and 12 months poststroke.
次要结局
- Action Research Arm Test (ARAT) Score(From enrollment to one year after enrollement)
- Jebsen-Taylor Hand Function Test (JTHFT) Time(From enrollement to one year after enrollment)
- Box and Blocks Test (BBT) Score(From enrollement to one year after enrollement)
- Hand-Held Dynamometry Grip Strength(From enrollement to one year after enrollment)
- Disabilities of the ARM, Shoulder, and Hand (DASH) Score(From enrollement to one year after enrollment)
- Resting Motor Threshold (RMT) via transcranial magnetic stimulation (TMS)(From enrollment to one year after enrollment)
- Motor evoked potential (MEP) Amplitude(From enrollement to one year after enrollment)
- MEP Latency(From enrollment to one year after enrollment)
- Interhemispheric inhibition (IHI) via PAS(From enrollment to one year after enrollment)
研究者
Iuly Treger MD
Director of Rehabilitation Department
Soroka University Medical Center