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Using Cerebrospinal Fluid Dynamics to Optimize Treatment of Idiopathic Normal Pressure Hydrocephalus

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ClinicalTrials.gov Identifier: NCT03076723
Recruitment Status : Enrolling by invitation
First Posted : March 10, 2017
Last Update Posted : September 25, 2019
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Uppsala University Hospital
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hydrocephalus, Normal Pressure Other: Change in shunt opening pressure Other: Simulated change in shunt opening pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arm Intervention/treatment
Sham Comparator: Fixed opening pressure
The shunt opening pressure is changed to the same setting as at surgery.
Other: Simulated change in shunt opening pressure
The shunt opening pressure is reset to the same setting.

Experimental: Individual 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).
Other: Change in shunt opening pressure
An individually determined change in shunt opening pressure is compared to no change in opening pressure.




Primary Outcome Measures :
  1. Change in total score on European INPH scale [ Time Frame: 3 and 6 months after surgery ]
    scale describing the cardinal symptoms of INPH

  2. Gait velocity [ Time Frame: 3 and 6 months after surgery ]
    Maximal gait velocity (3 x 10 m)

  3. 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

  4. Gait velocity [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Maximal gait velocity (3 x 10 m)


Secondary Outcome Measures :
  1. Computerized General Neuropsychological INPH Test (CoGNIT) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    A computerized neuropsychological test battery for use in INPH, which produces a total "neuropsychological" score

  2. Timed up and go test [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Mobility test: rise from chair, walk 3 m, turn around, walk back and sit down again

  3. EuroQoL's (EQ) standardized 5 dimensions (5D) 5 levels (5L) instrument (EQ-5D-5L™) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    EuroQoL's standardized instrument for health outcome, which assesses health in 5 dimensions, on 5 levels

  4. Urogenital Distress Inventory (UDI-6) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Continence assessment scale

  5. Incontinence Impact Questionnaire, Short Form (IIQ-7) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Continence assessment scale

  6. Barthel Index [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Activities of daily living assessment scale

  7. Modified Rankin scale [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Disability assessment scale

  8. Geriatric depression scale (GDS-15) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Score on a geriatric depression scale consisting of 15 yes/no questions

  9. Mini-mental state examination (MMSE) score [ Time Frame: baseline (before surgery) and 3 months after surgery ]
    Score on the MMSE scale (general mental status)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076723


Locations
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Finland
Kuopio university hospital
Kuopio, Finland, 70210
Turku university hospital
Turku, Finland, 20521
Sweden
Sahlgrenska university hospital
Gothenburg, Sweden, 41345
Umeå university hospital
Umeå, Sweden, 90185
The Uppsala university hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Umeå University
Sahlgrenska University Hospital, Sweden
Uppsala University Hospital
Investigators
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Principal Investigator: Jan Malm, MD, PhD Umeå University Hospital
Study Director: Sara Qvarlander, PhD Umeå University

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Responsible Party: Umeå University
ClinicalTrials.gov Identifier: NCT03076723     History of Changes
Other Study ID Numbers: UMU-2016-CSFD-PC
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases