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临床试验/NCT02168413
NCT02168413已完成不适用

Development of New Cortical Excitability Methodologies Using Robotised and Neuronavigated Transcranial Magnetic Stimulation.

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2014年5月14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
144
试验地点
1
主要终点
Electromyographic activity (EMG)

研究概览

简要总结

This study has two main goals :

  • to develop the cortcial excitbality (CE) measurement methodology using coupling between transcranial magnetic stimulation (TMS) and physiological recordings such as electroencephalography (EEG) and electromyography (EMG),
  • to automatize these measurements using robotized TMS.

Assessing CE is a preliminary and crucial step in any TMS protocol, in either fundamental or clinical research. It is an important indicator which determine the stimulation power applied on the cortical target during the TMS experiment, or during the rTMS cure (patients). CE is in general measured on the motor cortex using EMG activity as the main indicator of the system's response, whatever the real cortical target is located. The present study thus propose to generalize this measurement on other cortical areas in link with the actual targets, and using other external recordings such as EEG. Moreover, as neuronavigation systems significantly improved TMS precision in the past years, CE measurements could significantly gain to become fully automatized using robotized TMS.

详细描述

Eligibility Criteria :

CRITERIA OF INCLUSION

  • Major Topic (18 to 75)
  • Signed informed consent,
  • A medical examination must be done before participation in research,
  • Membership or beneficiary of a social security scheme,

CRITERIA OF NON-INCLUSION

  • Topic of under 18 and over 75 years.
  • Against-indications (CI) to the practice of MRI pacemaker or implantable defibrillator or pacemaker neurosensory (risk of temporary or permanent damage to the device or heating metal parts). Cochlear implants (risk of demagnetization, electrode temperature rise and artifacts). Ocular or cerebral ferromagnetic foreign body close to the nerve structures (risk of displacement and complications such as eye or brain damage). Metal prostheses (possibility of significant artifacts according to their size and their ferromagnetic character, some neurosurgical clips or heart valves can cause problems and require an investigation into the exact model implanted). Topics claustrophobic. Pregnant woman. Neurosurgical ventriculoperitoneal bypass valves. Irremovable metal braces.
  • CI practice of TMS: the history of epilepsy or seizures during hyperthermia during childhood are related ICs. Ferrométalliques body presence in the brain, cochlear implants, pacemakers, insulin pumps, during pregnancy, about jet lag or not having slept the night before the session of TMS.
  • Existence of a severe condition in general terms: cardiac, respiratory, hematologic, renal, hepatic, cancerous,
  • Regular Taking anxiolytics, sedatives, antidepressants, neuroleptics,
  • Psychiatric disorder characterized,
  • Alcohol ingestion before the examination,
  • Persons referred to in Articles L1121-5 to L1121-8 CSP.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult subjects (18 to 75 years old)
  • consent form signed
  • medical examination done prior to the experiment
  • affiliated to the French social security

排除标准

  • Exclusion criteria associated to MRI : pacemaker or neurosensory stimulator or implantable defibrillator. Cochlear implants. Ferromagnetic external bodies. Metal prosthesis. Claustrophobia. Pregnancy. Neurochirurgical bypass valves. Fixed metal dentures.
  • Exclusion criteria associated to TMS : seizures antecedent. Pacemaker or neurosensory stimulator or implantable defibrillator. Cochlear implants. Ferromagnetic external bodies. Pregnancy. Insulin pump. Jet-lag or sleep deprivation. Severe medical affliction. Regular doses of anxiolytics, sedatives, antidepressant, neuroleptic. Psychiatric illness. Alcool ingestion prior to the experiment.

结局指标

主要结局

Electromyographic activity (EMG)

时间窗: One hour

Participants' electromyographic activity will be recorded during an average of one hour.

次要结局

  • Electroencephalographic activity (EEG)(One hour)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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