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 University5 sites in 2 countries43 target enrollmentJune 13, 2017

ConditionsHydrocephalus, Normal Pressure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hydrocephalus, Normal Pressure
Sponsor: Umeå University
Enrollment: 43
Locations: 5
Primary Endpoint: European INPH scale
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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:

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.
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:

To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude.
To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery.
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.

Registry

clinicaltrials.gov

Start Date

June 13, 2017

End Date

December 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Umeå University

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

European INPH scale

Time Frame: 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

Time Frame: 3 and 6 months after surgery

scale describing the cardinal symptoms of INPH

Gait velocity

Time Frame: baseline (before surgery) and 3 months after surgery

Maximal gait velocity (3 x 10 m)

Secondary Outcomes

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)