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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
An individually determined change in shunt opening pressure is compared to no change in opening pressure.
The shunt opening pressure is reset to the same setting.
Kuopio university hospital
Kuopio, Finland
Turku university hospital
Turku, Finland
Sahlgrenska university hospital
Gothenburg, Sweden
Umeå university hospital
Umeå, Sweden
The Uppsala university hospital
Uppsala, Sweden
Change in total score on European INPH scale
scale describing the cardinal symptoms of INPH
Time frame: 3 and 6 months after surgery
Gait velocity
Maximal gait velocity (3 x 10 m)
Time frame: 3 and 6 months after surgery
European INPH scale
Change in total score on scale describing the cardinal symptoms of INPH
Time frame: baseline (before surgery) and 3 months after surgery
Gait velocity
Maximal gait velocity (3 x 10 m)
Time frame: baseline (before surgery) and 3 months after surgery
Computerized General Neuropsychological INPH Test (CoGNIT)
A computerized neuropsychological test battery for use in INPH, which produces a total "neuropsychological" score
Time frame: baseline (before surgery) and 3 months after surgery
Timed up and go test
Mobility test: rise from chair, walk 3 m, turn around, walk back and sit down again
Time frame: baseline (before surgery) and 3 months after surgery
EuroQoL's (EQ) standardized 5 dimensions (5D) 5 levels (5L) instrument (EQ-5D-5L™)
EuroQoL's standardized instrument for health outcome, which assesses health in 5 dimensions, on 5 levels
Time frame: baseline (before surgery) and 3 months after surgery
Urogenital Distress Inventory (UDI-6)
Continence assessment scale
Time frame: baseline (before surgery) and 3 months after surgery
Incontinence Impact Questionnaire, Short Form (IIQ-7)
Continence assessment scale
Time frame: baseline (before surgery) and 3 months after surgery
Barthel Index
Activities of daily living assessment scale
Time frame: baseline (before surgery) and 3 months after surgery
Modified Rankin scale
Disability assessment scale
Time frame: baseline (before surgery) and 3 months after surgery
Geriatric depression scale (GDS-15)
Score on a geriatric depression scale consisting of 15 yes/no questions
Time frame: baseline (before surgery) and 3 months after surgery
Mini-mental state examination (MMSE) score
Score on the MMSE scale (general mental status)
Time frame: baseline (before surgery) and 3 months after surgery
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