Hydrocephalus, Normal Pressure
Conditions
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.
Interventions
OTHERChange in shunt opening pressure
An individually determined change in shunt opening pressure is compared to no change in opening pressure.
OTHERSimulated change in shunt opening pressure
The shunt opening pressure is reset to the same setting.
Sponsors
Sahlgrenska University Hospital
Uppsala University Hospital
Kuopio University Hospital
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total score on European INPH scale | 3 and 6 months after surgery | scale describing the cardinal symptoms of INPH |
| Gait velocity | 3 and 6 months after surgery | Maximal gait velocity (3 x 10 m) |
| European INPH scale | baseline (before surgery) and 3 months after surgery | Change in total score on scale describing the cardinal symptoms of INPH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urogenital Distress Inventory (UDI-6) | baseline (before surgery) and 3 months after surgery | Continence assessment scale |
| 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 |
| 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 |
| 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 |
| Mini-mental state examination (MMSE) score | baseline (before surgery) and 3 months after surgery | Score on the MMSE scale (general mental status) |
| Modified Rankin scale | baseline (before surgery) and 3 months after surgery | Disability assessment scale |
| 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 |
| 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 |
Countries
Finland, Sweden
Outcome results
None listed