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临床试验/NCT06464445
NCT06464445招募中不适用

Defining Parameters to Optimize Neurostimulation for the Treatment of Pediatric Depression

Université de Sherbrooke2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
TMS derived measure of cortical plasticity

研究概览

简要总结

Repetitive TMS (rTMS) is a well-established method for modulating brain activity. Through successive stimulations in the form of magnetic fields, it is possible to modify the sensitivity of neurons in the brain, also known as cortical excitability. Cortical excitability is important for the induction of brain plasticity, the ability of the brain to reorganize itself and form new connections in response to stimuli. A particular class of rTMS, intermittent theta burst TMS (iTBS), is commonly used to modulate cortical excitability and induce plasticity for therapeutic purposes, notably for treatment-resistant depression.

Different iTBS stimulation parameters can be used to induce plasticity. This study will focus on two parameters, namely, the form and duration of the electromagnetic stimulation. The shape of the electromagnetic pulse refers to how the electromagnetic wave is configured over time, while the duration is simply the period during which this electromagnetic pulse remains active. These parameters are expected to influence the effectiveness of iTBS in modulating cortical activity but remain little studied.

The main aim of this study will be to compare the effectiveness of different stimulation parameters in the induction of plasticity, which will then make it possible to improve the rTMS protocols used for treatment-resistant depression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be between 18 and 35 years old
  • Be of right manual dominance
  • In good health

排除标准

  • Have an implant or pacemaker,
  • Having tinnitus,
  • Have a history of fainting,
  • Have already had an epileptic seizure or have a family history of epilepsy,
  • Have a known neurological disease,
  • Be under psychotropic medication,
  • Have suffered from substance abuse or dependence in the last 6 months,
  • Have a neurostimulator,
  • Have a splinter or metallic implant in the head or the rest of the body,
  • Have a cochlear implant,
  • Have an automated injection system implanted (insulin pump),
  • Have a transdermal patch,
  • Have tattoos in the area to be studied,
  • Be pregnant or breastfeeding,

结局指标

主要结局

TMS derived measure of cortical plasticity

时间窗: Pre-iTBS, Every 5 minutes post iTBS intervention up to 60 minutes post intervention.

Change in Peak-to-peak motor evoked potential (MEP) amplitude induced by the administration of the test stimulus (stimulation intensity required to produce an MEP of 1 millivolt, approximately 120% of rMT) after iTBS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-François Lepage

Full professor, Department of Pediatrics

Université de Sherbrooke

研究点 (2)

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