Contribution of Cerebral Pulsatility Assessment by Transcranial Ultrasound to the Decision-making for Cerebrospinal Fluid Shunting in Patients With Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH).
The neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol.
The primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05."
详细描述
This will be a prospective, single-center cohort study including patients with suspected idiopathic normal pressure hydrocephalus (iNPH). Eligibility will require fulfillment of inclusion criteria and confirmation of non-opposition after written informed consent procedures.
All patients will undergo transcranial pulse imaging (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization. Operated patients will have a second TPI assessment at 12 months post-surgery, while non-operated patients will undergo repeat TPI 12 months after baseline. Ultrasound assessments will be integrated into the standard hydrocephalus work-up.
The decision to perform cerebrospinal fluid (CSF) shunting will be made by the neurosurgical team blinded to ultrasound findings and based solely on standard clinical and radiological criteria. Baseline clinical (demographics, vascular risk factors, cognitive/gait/urinary symptoms, neurological history) and radiological variables (ventricular volume, Evans index, callosal angle, DESH, Radscale) will be collected.
During hospitalization, gait and cognitive function will be evaluated before and 48 hours after lumbar puncture. TPI will provide two indices of cerebral pulsatility: mean brain tissue pulsatility (MeanBTP) and maximal brain tissue pulsatility (MaxBTP), expressed as peak amplitude, peak amplitude mean, and root mean square.
Follow-up will include standardized clinical and radiological assessments. Non-operated patients will be evaluated at 12 months. Operated patients will be seen at 2 months and 12 months postoperatively, with documentation of complications, shunt valve settings, ventricular volume changes, and subdural collections.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected iNPH (= at least 1/3 of the triad symptoms + ventriculomegaly on brain imaging)
- •Hospitalised at Tours University Hospital for 'hydrocephalus assessment'
- •Patient who has provided written and signed consent
- •Non-inclusion criteria
- •Individuals who objected to data processing
- •Walking assessment by the physiotherapy team impossible AND cognitive assessment by the speech therapy team impossible
- •Exclusion criteria
- •Patients already fitted with a CSF shunting system (VPS)
- •Suspicion of obstructive hydrocephalus (aqueduct stenosis, tumour, etc.)
- •Patients under legal protection (guardianship, curatorship, judicial protection).
排除标准
- 未提供
结局指标
主要结局
Clinical improvement
时间窗: 12 months
Clinical improvement at 12 months in patients who undergo CSF shunt surgery (ventriculoperitoneal shunt, VPS). Clinical improvement will be defined as cognitive improvement at 12 months and/or gait improvement at 12 months. * Cognitive improvement: improvement in at least two cognitive tests. Improvement in a single test will be defined as an increase ≥ 1 standard deviation between the baseline pre-lumbar puncture (pre-LP) speech therapy evaluation and the 12-month postoperative assessment. * Gait improvement: improvement in the Get Up and Go test and/or the 10-meter walk test (10MWT) between baseline and the 12-month postoperative assessment.
次要结局
- 10-meter walk test(12 months)
- Mattis Dementia Rating Scale score (MDRS)(12 months)
- Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)(12 months)
- Get Up and Go test (s)(12 months)
- Reduction in modified Rankin Scale score (≤ 1 point compared with baseline) at 12 months(12 months)
- Reduction in ventricular volume (total ventricular volume and third ventricular volume) at 12 months(12 months)
- Shunt valve opening pressure (mmH₂O) at 12 months(12 months)