Effects of Transcranial Static Magnetic Field Stimulation (tSMS) on Motor Learning and Cortical Neurophysiology in the Developing Brain
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in amplitude of motor evoked potentials (MEPs)
研究概览
简要总结
Non-invasive brain stimulation (NIBS) is a safe, painless way to improve brain function. It is used for many conditions, including to help children with disabilities. However, it can be challenging to apply NIBS in very young children and infants. A new, simple form of NIBS called transcranial static magnetic field stimulation (tSMS) is a promising tool for early brain stimulation. tSMS in adults has been shown to be safe, tolerable and have the desired effects on brain activity when applied to the motor cortex of the brain. However, how tSMS affects on motor function is not understood. This research will use tSMS to target the motor cortex which is responsible for voluntary movement. The study will determine if tSMS can improve motor learning in healthy children. It is hypothesized that application of tSMS on the right motor cortex will decrease excitability of the motor cortex and will lead to improved motor learning in the right hand. tSMS has the potential to become a safe, inexpensive, home-based way to enhance personalized rehabilitation for disabled children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent/assent
- •age between 8 and 18 years
- •right-handedness
- •normal development
- •absence of neuropsychiatric diagnoses or medications
排除标准
- •diagnosis of a neurological, psychiatric or developmental disorder
- •metal in mouth, implanted pacemakers, or other contraindications for brain stimulation
- •confirmed or potential pregnancy
结局指标
主要结局
Change in amplitude of motor evoked potentials (MEPs)
时间窗: Change from baseline to immediately following the tSMS intervention
Baseline data will be collected through application of single Transcranial Magnetic Stimulation (TMS) pulses used to assess cortical excitability within one hemisphere. For this, two stimulators (Magstim and Bistim) are connected by an adaptor. A single flat iron Magnstim TMS coil is held over the right hotspot, and pairs of pulses is delivered from this coil. 10 test pulses at an intensity of 120% of resting motor threshold (RMT) are applied. These pulses will be randomized with other paired-pulses to collect other outcome measures (described in the secondary outcome measures section)
次要结局
- Change in left-hand Purdue Pegboard Test (PPT) score.(Change in left-hand Purdue Pegboard Test (PPT) score from baseline to after the tSMS intervention)
- Change in short-interval intracortical inhibition (SICI)(Change from baseline to immediately following the tSMS intervention)
- Change in intracortical facilitation (ICF)(Change from baseline to immediately following the tSMS intervention)
研究者
Adam Kirton
Professor of Pediatrics, Radiology, and Clinical Neurosciences; Director of Calgary Pediatric Stroke Program and N3; Pediatric Neurologist
University of Calgary