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临床试验/NCT03076723
NCT03076723终止不适用

Using Cerebrospinal Fluid Dynamics to Identify Shunt Responders in Idiopathic Normal Pressure Hydrocephalus and to Optimize Postoperative Clinical Improvement While Minimizing Overdrainage Related Complications - A Double Blind Randomized Study

Umeå University10 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2017年6月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
43
试验地点
10
主要终点
European INPH scale

研究概览

简要总结

The purpose of the study is to determine if the so called pulsatility curve, which describes the relationship between intracranial pressure (ICP) and ICP pulsatility, can be used to predict outcome of treatment, in the form of shunt surgery, in idiopathic normal pressure hydrocephalus (INPH) and to guide the adjustment of shunt opening pressure after the surgery. The main hypotheses of the study are:

  1. The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in INPH patients. With a "fixed" shunt opening pressure, the preoperatively assessed potential pulse amplitude reduction (determined by analysis of the pulsatility curve) predicts postoperative improvement in gait velocity and cognitive functions.
  2. A postoperative pulsatility curve can be used to further optimize ICP pulsatility by guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve three months postoperatively will increase improvement, but not complications, compared to a shunt with "fixed" opening pressure.

Based on these hypotheses, three specific aims for the study have been defined:

  1. To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude.
  2. To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery.
  3. To compare outcome six months after surgery and complications rates between INPH patients with a "fixed" opening pressure versus those where the shunt has been adjusted based on the pulsatility curve, three months after the shunt insertion.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Possible or probable INPH according to the INPH guidelines.
  • Symptom duration ≥ 3 months
  • Age ≥50 years
  • Able to walk 10 meters with or without an assistant device.
  • Decision to recommend shunt surgery based either on:
  • Improvement after cerebrospinal fluid (CSF) tap (i.e. positive tap test), or;
  • Increased CSF outflow resistance, or;
  • A combination of "typical" signs/symptoms + "typical" MRI findings;
  • A combination of a-c.

排除标准

  • NPH due to hemorrhage, meningitis or stroke (secondary NPH).
  • Symptom duration ≥ 5 years.
  • Patients considered surgical risk.
  • Baseline gait velocity >1.1 m/sec (60 m/min) without assistant device
  • Mini Mental State Exam score ≤ 20 points.
  • Musculoskeletal condition precluding gait assessment.
  • Severe hearing or visual impairment
  • Medication in the form of warfarin or novel oral anticoagulant (NOAC)
  • Insufficient pressure data below resting pressure during the CSF infusion investigation, i.e. no complete assessment of the pulsatility curve

结局指标

主要结局

European INPH scale

时间窗: baseline (before surgery) and 3 months after surgery

Change in total score on scale describing the cardinal symptoms of INPH

Change in total score on European INPH scale

时间窗: 3 and 6 months after surgery

scale describing the cardinal symptoms of INPH

Gait velocity

时间窗: baseline (before surgery) and 3 months after surgery

Maximal gait velocity (3 x 10 m)

次要结局

  • Computerized General Neuropsychological INPH Test (CoGNIT)(baseline (before surgery) and 3 months after surgery)
  • Timed up and go test(baseline (before surgery) and 3 months after surgery)
  • Barthel Index(baseline (before surgery) and 3 months after surgery)
  • Modified Rankin scale(baseline (before surgery) and 3 months after surgery)
  • Urogenital Distress Inventory (UDI-6)(baseline (before surgery) and 3 months after surgery)
  • Mini-mental state examination (MMSE) score(baseline (before surgery) and 3 months after surgery)
  • Incontinence Impact Questionnaire, Short Form (IIQ-7)(baseline (before surgery) and 3 months after surgery)
  • Geriatric depression scale (GDS-15)(baseline (before surgery) and 3 months after surgery)
  • EuroQoL's (EQ) standardized 5 dimensions (5D) 5 levels (5L) instrument (EQ-5D-5L™)(baseline (before surgery) and 3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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