Accelerating Motor Learning in Pediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Change in Left Hand Purdue Pegboard Test Score
研究概览
简要总结
Non-invasive brain stimulation can both study and potentially treat neurological disorders. Transcranial direct-current stimulation (tDCS) is an emerging safe and tolerability form of stimulation and has been used increasingly over the last decade.
The purpose of this research is to see if two different types of tDCS can improve motor function in healthy children. tDCS has been shown to safely enhance hand motor function in healthy adults, and those that have suffered stroke and other conditions. Recently the investigators demonstrated that tDCS may enhance hand motor function in healthy children, however, how it does so is unknown. In addition to assessing changes in motor function when tDCS is given during motor skill training, the investigators will perform various tests before and after stimulation to understand the changes that happen in the brain accompanying motor skill learning and brain stimulation.
The investigators hypothesize that there will be an accelerated acquisition of motor skill, when training is paired with conventional anodal tDCS, HD-tDCS, or sham tDCS.
详细描述
Background & rationale: Plasticity may be enhanced in the developing brain but mechanisms are poorly understood. Brain stimulation technologies such as transcranial direct-current stimulation (tDCS) modulate motor cortex excitability and plasticity. Studies by our group and others suggest that neuromodulation trials with tDCS are both safe and feasible in children. Recently the investigators demonstrated that conventional tDCS can enhance motor learning in healthy children. Additionally, recent advances in high-definition tDCS (HD-tDCS) have presented an opportunity to focally stimulate regions of the brain. HD-tDCS has not been investigated to date in children.
Establishing an ability of tDCS to enhance motor learning has therapeutic implications for children with motor disabilities. Perinatal stroke is the leading cause of hemiparetic cerebral palsy and most survivors suffer lifelong physical disability. Emerging models from our lab and others have defined central therapeutic targets whereby brain stimulation may enhance motor learning and function. Understand the effects of tDCS on motor learning, and it's underlying changes within the brain, is essential to advancing such interventions.
Research question & objectives: Here the investigators propose to characterize the effects of tDCS on motor learning in healthy children. The primary objective of this study is to determine changes in acquisition of motor skill, when training is paired with conventional anodal tDCS, HD-tDCS, or sham tDCS. Multiple secondary objectives will describe biochemical and sensorimotor changes in the brain that take place during motor learning paired with tDCS. Secondary objectives will also assess the safety of HD- tDCS in healthy children.
Ethics: This study has been approved by the University of Calgary Research Ethics Board.
Design: Randomized, double blind, sham-controlled trial to evaluate the ability of tDCS and HD-tDCS to enhance motor learning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 12-18 years
- •Right-handed
- •Normal development
- •No neuropsychiatric disorders, neuropsychotropic medications, or chronic medical conditions
- •Informed consent/assent
排除标准
- •Implanted electrical devices, including (but not limited to) cardiac pacemakers.
- •Metallic implants or irremovable metal objects
- •Pregnant females or females who may be pregnant.
- •Braces or upper teeth wires.
研究组 & 干预措施
Anodal Conventional tDCS
The intervention will be anodal conventional tDCS. Anodal tDCS: 30 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 30 second ramp down to 0 milliamp. Anode positioned over the right primary motor cortex, and the cathode over the contralateral supraorbital area.
干预措施: Anodal Conventional tDCS (Device)
Anodal High Definition tDCS
The intervention will be anodal high definition-tDCS. Anodal HD-tDCS: 30 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 30 second ramp down to 0milliamp. Anode entered over the right primary motor cortex, and four cathodes placed in a ring formation surrounding the anode.
干预措施: Anodal High Definition tDCS (Device)
Sham tDCS
Sham subjects will undergo exactly the same anodal conventional tDCS protocol as outlined above. This includes the initial stimulation sequence of ramp up of 30 seconds, generating the initial transient scalp sensations identical to the treatment group. The stimulator will be programmed by the technologist after 120 seconds of stimulation to automatically ramp down to 0milliamp over 30 seconds.
干预措施: Sham tDCS (Device)
结局指标
主要结局
Change in Left Hand Purdue Pegboard Test Score
时间窗: Baseline and immediately post-training on day 5
A "baseline" trial will be performed. Each day they will do 15 repetitions for 5 consecutive days. On the fifth day, they will do a post training trial consisting of 3 repetitions.
次要结局
- Percent change in metabolic markers(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in functional motor activations(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in motor function tasks - Serial Reaction Time test(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in robotic sensorimotor measures(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in vibro-tactile sensory measures(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in size of transcranial magnetic stimulation (TMS) motor maps(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in motor function tasks - Jebsen-Taylor test(Baseline, post-training on day 5, and 6 weeks following training)
- Raw change in motor function tasks - Purdue Pegboard test(Baseline, post-training on day 5, and 6 weeks following training)
研究者
Adam Kirton
Associate Professor
University of Calgary