Treatment in advanced Parkinson*s disease: continuous intrajejunal levodopa infusion versus deep brain stimulation; a feasibility study - INVEST (INfusion VErsus STimulation) feasibility study

Academisch Medisch Centrum0 个研究点目标入组 59 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•-idiopathic PD with bradykinesia and at least two of the following signs; resting tremor, rigidity, and asymmetry;
•-despite optimal pharmacological treatment at least one of the following symptoms: severe response fluctuations, dyskinesias, painful dystonias, or bradykinesia;
•-a life expectancy of more than two years.

•-age below 18 years;
•-previous PD-neurosurgery (e.g. DBS, pallidotomy, thalamotomy);
•-previous CLI (through a PEG-tube or Nasal Jejunal tube);
•-Hoehn and Yahr stage 5 at the best moment during the day;
•-a Montreal Cognitive Assessment score of 25 or less (MOCA; http://www.mocatest.org);
•-psychosis;
•-current depression despite optimal pharmacotherapy;
•-contraindications for DBS surgery, such as a physical disorder making surgery hazardous;
•-contraindications for PEG surgery and Duodopa;
•-pregnancy, breastfeeding, and women of child bearing age not using a reliable method of contraception;
•-inability to provide written informed consent;
•-legally incompetent adults.

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