MRI-Volumetry in the Evaluation of Shunt Treatment for Hydrocephalus, a Randomised, Double-blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Time of "Timed Up and Go" test at different shunt settings
研究概览
简要总结
This randomized, double-blinded, cross-over study aim to evaluate the effects of shunt treatment in idiopathic normal pressure hydrocephalus (iNPH) by measuring cerebral ventricular volume and clinical symptoms at different shunt opening pressures. Further, proteins in the cerebrospinal fluid (CSF) will be compared before and after shunt surgery.
详细描述
The participants are evaluated before surgery and one month, two months, three months and three months plus one day after surgery. At each evaluation point a MRI of the brain with volumetric sequences is performed and clinical data is collected (Walking speed and steps for Time up and go, 10m walking and 3m walking backwards. Mini Mental State Examination, balance, gait, self rating of incontinence, Epworth Sleepiness Scale).
At surgery, all patients are given a ventriculoperitoneal (VP) shunt (Strata ® ) with an opening pressure setting of 1.5. After the first evaluation, one month postoperatively, participants are randomized to either a higher (2.5) or a lower (1.0) opening pressure, ratio 1:1. The opening pressure setting is blinded both for patients and the clinician during the subsequent clinical evaluations. At two months, the opening pressure is crossed over to the alternative setting (2.5 or 1.0). At three months, all participants receive the lowest shunt opening pressure (0.5) with the final evaluation the next day.
Semiautomatic measurement of the lateral as well as the third cerebral ventricles will be performed using the MRI scans and volumetric software: SyMRI (SyntheticMR AB, Linköping, Sweden)
CSF is collected at three times for each participant, from the lumbar spine pre- and 3 months postoperatively and intracranially during surgery. Further, intracranial CSF is taken through the Rickham Reservoir at the 3 months postoperative evaluation. After CSF from the participants has been collected, a single batch mass spectrometry will be performed with all the samples simultaneously.
Sample size was determined to achieve 80% power for a two tailed paired t-test for a mean change in ventricular volume of 8ml, estimated from postoperative change in ventricular volume in a previous study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Shunt setting at the two months and three months follow up.
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
- •Diagnosis of idiopathic normal pressure hydrocephalus and planned treatment with shunt surgery.
排除标准
- •Ongoing anticoagulation treatment
- •Ongoing Clopidogrel treatment
- •Mini mental state examination results of 15 or lower.
- •Contraindications to magnetic resonance imaging.
结局指标
主要结局
Time of "Timed Up and Go" test at different shunt settings
时间窗: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Change in total walking time (sec) on "Timed Up and Go".
Ventricular volume at different shunt settings (mL)
时间窗: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Change in ventricular volume (ml) measured by MRI
Time of 10m walking test at different shunt settings
时间窗: Assessed before surgery and at one, two and, three months and three months plus one day post surgery.
Change in total walking time (sec) on 10m walking test.
次要结局
- Time of 3m backwards walking test at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Number of steps on 3m backwards walking test at different shunt settings(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Continence scale at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Number of steps of "Timed Up and Go" test at different shunt settings(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Ventricular versus lumbar cerebrospinal fluid composition determined by mass spectrometry(Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.)
- Number of steps on 10m walking test at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Change in CSF composition after surgery determined by mass spectrometry(Cerebrospinal fluid is collected during diagnostic procedures before surgery, during surgery and three months and one day after surgery.)
- Time of 3m backwards walking test at different shunt settings(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Number of steps of "Timed Up and Go" test at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Number of steps on 10m walking test at different shunt settings(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Number of steps on 3m backwards walking test at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Mini Mental State Examination at different shunt settings(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Mini Mental State Examination at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Continence scale at different shunt settings.(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Balance scale at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Gray matter volume at different shunt settings.(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Balance scale at different shunt settings.(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Epworth sleepiness scale at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Epworth sleepiness scale at different shunt settings(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Time of 10m walking test at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Modified rankin scale at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Modified rankin scale at different shunt settings.(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Gray matter volume at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Time of "Timed Up and Go" test at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- White matter volume at different time points regardless of shunt setting(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- White matter volume at different shunt settings.(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
- Ventricular volume at different time points regardless of shunt setting (mL)(Assessed before surgery and at one, two and, three months and three months plus one day post surgery.)
研究者
Katarina Laurell
Senior Lecturer/Associate Professor
Uppsala University