Impact of Repetitive Transcranial Magnetic Stimulation (TMS) on Spike Frequency and Brain Connectivity in Children With Benign Epilepsy With Centrotemporal Spike (BECTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Interictal Epileptiform Discharge (IED) Frequency
研究概览
简要总结
Benign epilepsy with centrotemporal spikes (BECTS) is the most common pediatric epilepsy syndrome. Affected children typically have a mild seizure disorder, but yet have moderate difficulties with language, learning and attention that impact quality of life more than the seizures. Separate from the seizures, these children have very frequent abnormal activity in their brain known as interictal epileptiform discharges (IEDs, or spikes), which physicians currently do not treat. These IEDs arise near the motor cortex, a region in the brain that controls movement.
In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of IEDs on brain regions important for language to investigate: (1) if treatment of IEDs could improve language; and (2) if brain stimulation may be a treatment option for children with epilepsy.
Participating children will wear electroencephalogram (EEG) caps to measure brain activity. The investigators will use TMS to stimulate the brain region where the IEDs originate to measure how this region is connected to other brain regions. Children will then receive a special form of TMS called repetitive TMS (rTMS) that briefly reduces brain excitability. The study will measure if IEDs decrease and if brain connectivity changes after rTMS is applied.
The investigators hypothesize that the IEDs cause language problems by increasing connectivity between the motor cortex and language regions. The investigators further hypothesize that rTMS will reduce the frequency of IEDs and also reduce connectivity between the motor and language region
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of Benign Epilepsy with Centrotemporal Spikes (BECTS), sometimes called Rolandic Epilepsy. Diagnosis will be based on a history of a focal motor seizure (affecting the face or causing hypersalivation) or a history of a seizure out of sleep AND an EEG with unilateral or bilateral centrotemporal spike waves.
- •English-speaking
排除标准
- •History of prematurity < 35 weeks gestational age;
- •History of serious neurologic problems (i.e. history of other seizure disorder other than simple febrile seizure, head trauma with prolonged loss of consciousness, cerebrovascular accident or neuro-inflammatory disease)
- •Focal deficits on neurologic exam
- •History of abnormal MRI (with clear gray or white matter abnormality)
研究组 & 干预措施
Children with BECTS
Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week.
干预措施: Active rTMS (Device)
Children with BECTS
Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week.
干预措施: Sham rTMS (Device)
结局指标
主要结局
Interictal Epileptiform Discharge (IED) Frequency
时间窗: Before and after intervention (approximately 4 hours/visit on 2 study days one week apart)
We will count the number of IEDs/minute before and after application of active rTMS as well as before and after sham rTMS. We will compare the change in IEDs induced by the active and sham stimulation.
次要结局
- Change in Brain Connectivity(Before and after intervention (approximately 4 hours/visit on 2 study days one week apart))
- Change in Brain Connectivity(Before and after intervention (approximately 4 hours/visit on 2 study days one week apart))
研究者
Fiona Baumer
Instructor
Stanford University