Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Assisting hand assessment
研究概览
简要总结
Unilateral spastic cerebral palsy (USCP) leads to life-long impairment with a hemiparesis of the affected side of the body. Rehabilitation efforts combine evidence based methods such as constrained induced movement therapy (CIMT) or hand-arm bimanual intensive therapy (HABIT) as well as training in daily life activities and psychological support in order to improve participation. It has been tried to enhance hand motor function trainings with non-invasive brain stimulation. However, evidence of this promising approach is limited. This might be due to a non-consideration of the individually different types of cortico-spinal projections to the paretic hand that demonstrated to be of highly relevant for the therapy of these children. Approximately one third of such patients control their paretic hands via crossed projections from the affected hemisphere (CONTRA), while one third uses ipsilateral projections from the contralesional hemisphere (IPSI). This study aims - for the first time - to enhance the effects of the training by priming the primary motor cortex (M1) of the paretic hand with a newly established high frequency quadri-pulse theta burst stimulation (qTBS) in a randomized, patient and evaluator blind, sham-controlled approach, for the first time taking the individual type of cortico-spinal reorganization (CONTRA vs IPSI) into account. This promising and neurophysiologically motivated approach is likely to ameliorate hand function in children with USCP.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Assured diagnosis of USCP.
- •Children aged 6 to 18 years with USCP
- •Dated and signed informed consent of legal guardian, informed assent from minor
排除标准
- •Therapy refractory epilepsy
- •Seizures within the last 2 years
- •More than 1 anti epileptic drugs
- •Implanted shunt system
- •If singular primary motor cortex cannot be identified by TMS, e.g. because of bilateral cortico-spinal reorganization or resting motor threshold above 80% maximum stimulator output (MSO)
- •Severe mental retardation
- •Psychiatric diseases
- •Uncooperative patients
结局指标
主要结局
Assisting hand assessment
时间窗: 10 days
Difference in change of logit assisting hand assessment scores between the TMS and sham-TMS group from baseline to end of 10 days intensive hand function training.
次要结局
- Corticospinal reorganization(1 year)
- Assisting hand assessement - Follow up(1 year)
- Neuronal plasticity(1 year)
- Assisting hand assessement - smallest detectable difference(1 year)
- Box-and-blocks test(1 year)
- Goal attainment scaling(1 year)
- Canadian occupational performance measure(1 year)
