A Blinded Randomized Sham-Controlled Incomplete Crossover Trial of Low-Frequency Contralesional Repetitive Transcranial Magnetic Stimulation in the Treatment of Aphasia in Patients With Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Boston Naming Test
研究概览
简要总结
Stroke often causes substantial problems in speaking or understanding speech. Treatments for these problems are currently very limited. Limited studies to date suggest that repetitive Transcranial Magnetic Stimulation (TMS) to the side of the brain opposite to the side on which the stroke occurred may improve language function. The investigators are testing this hypothesis by giving daily 20 minute sessions of repeated TMS to the right (unaffected) side of the brain; the investigators test language function with a variety of tests both before and after the treatment with TMS and subjects are required to undergo functional MRI scans before and after treatment. TMS is a procedure in which a coil is placed next to the head of the subject and an electrical current passes through the coil causing a magnetic field that, in turn, causes a small electric current in the portion of the brain underneath the coil.
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, Care Provider)
盲法说明
The procedure for localizing the site of stimulation and TMS administration will be identical to the treatment arm, except the coil will be rotated 90 degrees during the process/administration.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aphasic patients will have had single, unilateral left hemisphere ischemic stroke, which spared the supplementary motor area (SMA)
- •With the exception of lacunar infarcts less than ≤ 1.5 cm (as measured by neuroimaging), the stroke causing the patients' impairments must be the only stroke.
- •Aphasic patients will be at least 6 months post-stroke and have mild-severe, non-fluent speech
- •Participants must be able to understand the nature of the study, and give informed consent
排除标准
- •Patients with more than one stroke
- •Primary hemorrhagic stroke. Note: It is recognized that some ischemic strokes may have a minor amount of hemosiderin in the parenchyma. If this occurs, this is not considered a "hemorrhagic stroke" referred to in this exclusion criterion.
- •Intracranial metallic bodies from prior neurosurgical procedure
- •Signs of increased intracranial pressure as assessed by ophthalmic exam and patient symptoms
- •Implanted pacemaker, medication pump, vagal nerve stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt
- •History of seizure or unexplained loss of consciousness during the year prior to the initiation of the study
- •Pregnancy. If the patient cannot rule out pregnancy then a pregnancy test will be conducted prior to inclusion into the study
- •Family history of epilepsy
- •Acute, unstable medical conditions
- •History of substance abuse within the last 6 months
- •Abnormal neurologic exam other than as signs of the condition studied in the present protocol
- •History of known structural brain abnormality other than as signs of the condition studied in the present protocol
- •History of tinnitus
- •History of bipolar disorder
- •Consumption of medicines known to lower the seizure threshold
- •History of head injury with unconsciousness lasting more than 5 minutes
- •Previous brain surgery
- •Other medical or neurologic conditions, aside from stroke, in which the likelihood of developing a seizure is known to be increased
- •Other medical or neurologic conditions, in which a seizure would be particularly harmful
- •Significant cardiac disease
- •Intracardiac lines of any type
- •Current serious or unstable medical illness, including renal, hepatic, cardiovascular, gastrointestinal, endocrinologic, neurologic, immunologic, or hematological disease, that could require admission to a hospital within 3 months, or that death is anticipated within 3 years, or that requires daily supervision by a health professional
- •Administration of any investigational drug within 5 half-lives of the drug prior to testing
结局指标
主要结局
Boston Naming Test
时间窗: Baseline, 2 months and 6-months after the last rTMS treatment session
The Boston Naming Test is an assessment of confrontation naming, where a score ranges from 0 (no items named correctly) to 36 (all items named correctly)
次要结局
未报告次要终点
研究者
H. Branch Coslett
Professor of Neurology
University of Pennsylvania