Effects of Repetitive Transcranial Magnetic Stimulation Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- BNT (Boston naming test)
研究概览
简要总结
The aim of this study is to assess the safety and clinical efficacy of high or low-frequency repetitive transcranial magnetic stimulation based on brain activation with functional near infrared spectroscopy in poststroke nonfluent aphasia patients.
详细描述
In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory protocol to reduce activities in the contralesional area. However, most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.
In the present pilot study, investigators will perform functional near-infrared spectroscopy (fNIRS) prior to rTMS treatment for selection of the most appropriate application of stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be determined by activation pattern from the fNIRS findings with language task in individual patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •18-80 yrs old
- •Right-handed
- •Radiologically confirmed left hemisphere stroke
- •Fluent in Korean
- •First ever stroke
- •More than 1 year from stroke onset
- •Non-fluent (motor-dominant) aphasia
- •Written informed consent
排除标准
- •Previous medical histories of stroke, cerebral vascular operation, seizure
- •Patients with traumatic brain injury
- •Unable to perform the language task
- •Severe cognitive impairment (MMSE less than 16)
- •Skin lesion in the stimulation site of scalp
- •Metal implants in the body (cardiac pacemaker or aneurysm clip)
- •Pregnancy, Breastfeeding
研究组 & 干预措施
High frequency rTMS
Most activated area from fNIRS with language task: Perileisional Broca's area
干预措施: High frequency rTMS (Device)
Low Frequency rTMS
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
干预措施: Low frequency rTMS (Device)
结局指标
主要结局
BNT (Boston naming test)
时间窗: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)
speech evaluation tool for measuring the confrontational word retrieval function
次要结局
- WAB (Western aphasia battery)(Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy))
- Laterality index (LI)(Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy))
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital