跳至主要内容
临床试验/NCT01959373
NCT01959373暂停不适用

Dysfunctions and Plasticity Mechanisms of Motor System Assessed by Cortico-cortical and Cortico-muscular Coherence Analysis in Amyotrophic Lateral Sclerosis

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
30
试验地点
2
主要终点
recording neuronal activities

研究概览

简要总结

Amyotrophic lateral sclerosis (ALS) is characterized clinically by abnormalities of both upper motor neurons (UMN) and lower motor neurons (LMN). The presence of UMN signs is not always easy to establish. The only technique used in routine to assess the corticospinal dysfunctions is based on transcranial magnetic stimulation (TMS). However, this technique is largely dependent on LMN state and is based on artificial motor cortex activation.

The main objective of our study project is to evaluate a new method assessing functional changes in motor system in ALS patients. By using cortico-muscular and cortico-cortical coherences, it could be possible to show modifications in both cortico-muscular relationship and in cortical activity coordination which could be related to clinical state in ALS patients. We notably expect a decrease in cortico-muscular coherence in ALS patients. Furthermore, these analyses could provide new insights in motor system plasticity phenomena. We expect a partial covering of voluntary motor command by cortical areas adjacent to primary motor cortex. Lastly, the hypothesis that an increased proportion of voluntary motor control may be assumed by ipsilateral corticospinal tract could be tested by coherence analyses.

Coherence analysis might be a useful method to detect corticospinal tract dysfunctions. This method has the advantage to be painless and not to use artificial stimulations as it is used in TMS.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient female or male, more than 18 years,
  • Patien with a diagnosis of amyotrophic lateral sclerosis according to the El Escorial criteria of Brooks et al. 1994
  • Patient , the beginning of the SLA date less than 12 months,
  • Patient not having a familial form of ALS,
  • Patient not having cancer, autoimmune disease, liver failure, severe hypertension or untreated, severe conduction disorders or uncontrolled arrhythmia
  • Patient not having a chronic psychiatric disease, dementia.
  • Patient with normal visual function
  • Patients receiving social coverage
  • Patient have read, understood and signed an informed consent after information

排除标准

  • Patient minor
  • Patient with a familial form of ALS,
  • Patient associated with severe progressive disease (cancer, autoimmune disease , liver failure )
  • Patient (s) with chronic mental illness, dementia ,
  • Presence of atypical clinical signs such as cerebellar ataxia , extrapyramidal signs, sensory disorders , autonomic dysfunction .
  • Clinical signs of chronic respiratory failure or slow and / or forced less than 70% of the theoretical value or chronic hypercapnia than 45 mmHg vital capacity .
  • Patient private freedom following a judicial or administrative decision
  • Patient major Trust
  • Pateinte pregnant, parturient , lactating
  • Patient major in legal protection ( guardianship )
  • Pateinte pregnant , parturient , lactating
  • Patient hospital without consent
  • Patient admitted in a health or social establishment for purposes other than research

结局指标

主要结局

recording neuronal activities

时间窗: 12 months

simultaneous recording of brain activity using electrodes attached to the scalp and muscle activities of muscles of the hands with electrodes bonded to the skin.

次要结局

  • identify plasticity phenomena(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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