Using Cerebrospinal Fluid Dynamics to Optimize Treatment of Idiopathic Normal Pressure Hydrocephalus
- Conditions
- Hydrocephalus, Normal Pressure
- Interventions
- Other: Simulated change in shunt opening pressureOther: Change in shunt opening pressure
- Registration Number
- NCT03076723
- Lead Sponsor
- Umeå University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 43
-
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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fixed opening pressure Simulated change in shunt opening pressure The shunt opening pressure is changed to the same setting as at surgery. Individual shunt opening pressure Change in shunt opening pressure The shunt opening pressure is adjusted (up one step, down one step or unchanged) according to an individual analysis of the pulsatility curve (as assessed after shunt surgery).
- Primary Outcome Measures
Name Time Method European INPH scale 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 3 and 6 months after surgery scale describing the cardinal symptoms of INPH
Gait velocity baseline (before surgery) and 3 months after surgery Maximal gait velocity (3 x 10 m)
- Secondary Outcome Measures
Name Time Method Computerized General Neuropsychological INPH Test (CoGNIT) baseline (before surgery) and 3 months after surgery A computerized neuropsychological test battery for use in INPH, which produces a total "neuropsychological" score
Timed up and go test baseline (before surgery) and 3 months after surgery Mobility test: rise from chair, walk 3 m, turn around, walk back and sit down again
Urogenital Distress Inventory (UDI-6) baseline (before surgery) and 3 months after surgery Continence assessment scale
Mini-mental state examination (MMSE) score baseline (before surgery) and 3 months after surgery Score on the MMSE scale (general mental status)
Incontinence Impact Questionnaire, Short Form (IIQ-7) baseline (before surgery) and 3 months after surgery Continence assessment scale
Barthel Index baseline (before surgery) and 3 months after surgery Activities of daily living assessment scale
Modified Rankin scale baseline (before surgery) and 3 months after surgery Disability assessment scale
Geriatric depression scale (GDS-15) baseline (before surgery) and 3 months after surgery Score on a geriatric depression scale consisting of 15 yes/no questions
EuroQoL's (EQ) standardized 5 dimensions (5D) 5 levels (5L) instrument (EQ-5D-5L™) baseline (before surgery) and 3 months after surgery EuroQoL's standardized instrument for health outcome, which assesses health in 5 dimensions, on 5 levels
Trial Locations
- Locations (5)
Turku university hospital
🇫🇮Turku, Finland
Kuopio university hospital
🇫🇮Kuopio, Finland
Umeå university hospital
🇸🇪Umeå, Sweden
Sahlgrenska university hospital
🇸🇪Gothenburg, Sweden
The Uppsala university hospital
🇸🇪Uppsala, Sweden