Endoscopic Third Ventriculostomy Compared to Ventriculoperitoneal Shunt as Treatment for Idiopathic Normal Pressure Hydrocephalus (ENDOVEST): A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- idiopathic normal pressure hydrocephalus (iNPH) score
研究概览
简要总结
The aim of this single-center, two-arm, open-labeled, randomized controlled clinical study is to compare two surgical interventions, endoscopic third ventriculostomy and ventriculoperitoneal shunt, in treating idiopathic normal pressure hydrocephalus in terms of clinical improvement.
详细描述
Idiopathic normal pressure hydrocephalus (iNPH) primarily affects elderly individuals, with prevalence rates of approximately 1.4% among those over 65 years and 5.9% among those over 80 years old. It is characterized by fluid buildup in the brain with normal cerebrospinal fluid pressure and is unique among neurodegenerative disorders in its potential for successful treatment. Common symptoms include difficulty walking, urinary incontinence, and cognitive decline, which significantly impact quality of life.
The standard treatment involves inserting a ventriculoperitoneal shunt (VPS) to drain cerebrospinal fluid, achieving a 75% success rate in improving symptoms. However, VPS has a drawback: a high rate of revision surgery (approximately 18% during follow-up). An alternative treatment is endoscopic third ventriculostomy (ETV), which avoids placing foreign materials and thus eliminates risks associated with shunt malfunction and infections. ETV is an established neuroendoscopic procedure mainly used to treat non-communicating hydrocephalus, typically due to aqueduct stenosis.
This study aims to compare ETV and VPS for the treatment of iNPH to investigate whether ETV leads to fewer complications while achieving a comparable rate of postoperative symptom improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>40 years of age
- •Symptom duration ≥3 months, <24 months
- •No antecedent head trauma, ICH, meningitis, or other cause of secondary hydrocephalus
- •MUST show gait/balance disturbance, PLUS cognition impairment AND/OR urinary dysfunction.
- •Ventricular enlargement (Evans Index > 0.3) not attributable to cerebral atrophy or congenital enlargement
- •No macroscopic obstruction to cerebrospinal fluid (CSF) flow Spinal Tap-Test
- •Opening pressure (on lateral decubitus): <24cmH2O
- •Clinical improvement in at least one of the main symptoms after 40-50ml withdrawal of CSF
排除标准
- •≤40 years of age
- •No informed consent
- •Other neurologic, psychiatric or general medical condition which is sufficient to explain the presenting symptoms.
- •Previous cranial neurosurgical interventions
- •Other associated dementia syndromes
- •Incapacity to walk
- •Pregnancy and breastfeeding women
结局指标
主要结局
idiopathic normal pressure hydrocephalus (iNPH) score
时间窗: Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery
The idiopathic normal pressure hydrocephalus (iNPH) score is used to measure the clinical improvement and complication rate. The iNPH score evaluates the three cardinal symptoms of iNPH-gait disturbance, dementia, and urinary incontinence-with each category assigned a score between 0 and 4 based on severity, resulting in a total score ranging from 0 (indicating normal) to 12 (reflecting the maximum severity of symptoms The score will be assessed during the outpatient consultation before surgery, at admission directly preceding surgery, and postoperatively at discharge, as well as during follow-up at 6-8 weeks, 6 months, and 12 months after the operation.
次要结局
- CERAD Constructive Praxis(At 2 and 12 months after surgery)
- Level of consciousness (Glasgow Coma Scale)(Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery)
- Degree of disability and dependency (modified Rankin Scale)(Up to 5 days, 2, 6, and 12 months after surgery)
- Cognitive function (Montreal Cognitive Assessment)(Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery)
- GaitRite walkway(At 2 and 12 months after surgery)
- Timed-Up-and-Go Test(At 2 and 12 months after surgery)
- Modified Clinical Test of Sensory Interaction on Balance(At 2 and 12 months after surgery)
- Modified Balance Error Scoring System(Before surgery (baseline), at 2 and 12 months after surgery)
- 5-times-sit-to-stand test(At 2 and 12 months after surgery)
- Hand grip strength test(At 2 and 12 months after surgery)
- Montreal Cognitive Assessment(At 2 and 12 months after surgery)
- Test of Attentional Performance(At 2 and 12 months after surgery)
- Trail Making Test(At 2 and 12 months after surgery)
- Stroop-Test(At 2 and 12 months after surgery)
- CERAD Word List(At 2 and 12 months after surgery)
- Intensity of depression (Beck Depression Inventory)(Before surgery (baseline), at 2 and 12 months after surgery)
- iNPH severity(Before surgery (baseline), up to 5 days, 2, 6, and 12 months after surgery)
- Boston Naming Test(At 2 and 12 months after surgery)
- Flow-void presence(Up to 5 days, 2, 6, and 12 months after surgery)
- Ventricular volumetry(Up to 5 days, 2, 6, and 12 months after surgery)
- Periventricular perfusion measurements(Up to 5 days, 2, 6, and 12 months after surgery)
- Evaluation of complications(Up to 5 days, 2, 6, and 12 months after surgery)
- Rey-Osterrieth Complex Figure Test(At 2 and 12 months after surgery)
- iNPH Radiological Scale(Up to 5 days, 2, 6, and 12 months after surgery)
- Health-related quality of life(At 2, 6, and 12 months after surgery)
- Evaluation of revision surgery(Up to 5 days, 2, 6, and 12 months after surgery)
- Mortality(Up to 5 days, 2, 6, and 12 months after surgery)