跳至主要内容
临床试验/NCT06799923
NCT06799923招募中不适用

Possibilities of Use Magnetic Resonance Imaging (MRI)-Guided Laser Interstitial Thermal Therapy (LITT) in Treatment of Medically Intractable Tremor

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 15 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
15
试验地点
2
主要终点
Variation of total body weight from baseline

研究概览

简要总结

Medically intractable tremors are a common difficult clinical situation. Deep brain stimulation decreases Parkinson's disease tremor and essential tremor, but not all patients are candidates from a diagnostic, medical, or social standpoint, prompting the need for alternative surgical strategies. Less invasive lesional brain surgery (thalamotomy) procedures by radio-surgery or MRI-guided focused ultrasound have emerged and have proven to be effective in these third-line indications. Recently, a new technology has emerged allowing the performance of minimally invasive lesion surgeries by MRI-Guided Laser Interstitial Thermal Therapy (MRIg-LITT). MRIg-LITT has been shown to be effective and safe in management of epilepsies and brain tumors. However, no study has evaluated MRIg-LITT for performing thalamotomy in medically intractable tremor.In a pilot study, the investigators propose to evaluate the effect and safety of unilateral thalamotomy by MRIg-LITT in the management of medically intractable tremor of parkinsonian or essential origin.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • Patients 18 years age or older with Parkinson's disease or essential tremor and tremor resistant to medical therapy with a contraindication to deep brain stimulation or refusal deep brain stimulation

排除标准

  • Contraindication to MRI
  • Contraindication to general anesthesia
  • Patient unable to give their free and informed consent because of cognitive or psychiatric disorders
  • Brain anatomical abnormalities not allowing intervention
  • Adults protected (guardianship, curators) or deprived of liberty.

结局指标

主要结局

Variation of total body weight from baseline

时间窗: at 72 hours

To assess the impact of UF prescription guided by the ECW/TBWat ratio on weight loss, a comparison of TBW (∆TBW) between the two groups will be conducted. The ∆TBW is the difference between the initial TBW at H0 and the TBW at H72.

次要结局

  • cumulative fluid balance(at 72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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