跳至主要内容
临床试验/NCT05165472
NCT05165472Unknown不适用

Priming Effects of Ultra-high Frequency Quattro Pulse Transcranial Brain Stimulation Prior to Hand Motor Function Training in Children With Unilateral Spastic Cerebral Palsy

Technical University of Munich4 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年7月1日最近更新:
适应症

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

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)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验