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临床试验/NCT05825274
NCT05825274已完成不适用

Transcranial Direct Current Estimulation for the Treatment of Drug-resistant Epilepsy in Children

Spanish Foundation for Neurometrics Development2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Body mass index

研究概览

简要总结

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. It encompass a wide spectrum of conditions, intensities and seizure types; therefor, several drugs have proven to treat different types of seizures. However, around 22.5 % of patients are unable to attain control regardless of the drug used or even a combination of several of them. TDCs offers a non-invasive approach with a focal effect for those patients. The focus of this study is to define the role for tDCS in the treatment of drug-resistant epilepsy on children.

详细描述

Epilepsy is the fourth overall neurologic disorder, regardless of age and gender. There are between 16 and 51 new cases per 100 000 people every year. A community-based study conducted in France concluded that up to 22.5 % of patients could be classified as presenting drug-resistant epilepsy. This group presents significant hazards such as an increased risk of death, injuries, psychosocial disfunction and a reduced quality of life. The International League against Epilepsy defines drug-resistant epilepsy as follows: A failure of adequate trials of two (or more) tolerated, appropriately chosen, appropriately used antiepileptic drugs (whether administered as monotherapies or in a combination) to achieve freedom from seizures. This significant amount of patients are the drive to develop different approaches in order to offer alternatives for control. In this regard, non-invasive brain stimulation protocols lead the way, since the pathophysiological substrate of epilepsy is an enhanced cortical excitability, leading to paroxysmal depolarisation shifts, an enhanced probability of high-frequent and hypersyncronous activity of small neuronal networks and the abnormal spreading of this pathological activity along cortico-cortical and cortico-subcortical neuronal conections. Transcranial direct current stimulation (tDCS) consists of short-lasting electric stimulus delivered to specific brain regions. When delivered repidetly, it generates long-lasting cortical excitability alterations and thus, has the potential to treat epilepsy targeting to the specific brain region where the cortical excitability is alterated. The aim of this study is to define the role for tDCS on the treatment of drug resistant epilepsy on children.

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
None

盲法说明

we use in half of patient cathodal tDCS or Brain noninvasive stimulation

入排标准

年龄范围
18 Months 至 120 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Age 18-90 montths
  • Having tried at least two appropriate anti-epileptic drugs (AEDs) tested to tolerance or to blood levels at upper end of the target range of which at least 2 have been tolerated at normal dose.
  • At least 2-3 seizure per month documented with EEG, not only clinically.
  • In good health except epilepsy.
  • Patients or his(her) familys could understand this method and sign the informed consent 7)Patients with good compliance and could complete postoperative follow-up.

排除标准

  • Results of MRI remind epilepsy caused by intracranial space-occupying lesions.
  • Tumor, cardiopulmonary anomaly, progressive neurological diseases, asthma,mental disease,pepticulcer,diabetes Type 1,bad health etc, and other surgical contraindication
  • sleep-related breathing disorders

结局指标

主要结局

Body mass index

时间窗: 4 Months

kg / m\^2

Decrease in number of crisis per day

时间窗: 4 months

Improve epilepsy and EEG (NO statistically and clinically significant spikes or slow waves were observed in EEG)., and changes in scale: QUALITY OF LIFE IN EPILEPSY - QOLIE-31

次要结局

  • Quality live improve(4 months)
  • Kessler Foundation Neglect Assessment Process(4 Months)

研究者

发起方
Spanish Foundation for Neurometrics Development
申办方类型
Other
责任方
Principal Investigator
主要研究者

Moises Domingo

Director Spanish Foundation for Neurometrics Development

Spanish Foundation for Neurometrics Development

研究点 (2)

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