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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Using Cerebrospinal Fluid Dynamics to Identify Shunt Responders in Idiopathic Normal Pressure Hydrocephalus and to Optimize Postoperative Clinical Improvement While Minimi

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

    Detailed Summary:
    Sponsor: Umeå University

    Current Primary Outcome:

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


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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
    • 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
    • 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
    • Urogenital Distress Inventory (UDI-6) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Continence assessment scale
    • Incontinence Impact Questionnaire, Short Form (IIQ-7) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Continence assessment scale
    • Barthel Index [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Activities of daily living assessment scale
    • Modified Rankin scale [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Disability assessment scale
    • 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
    • Mini-mental state examination (MMSE) score [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Score on the MMSE scale (general mental status)


    Original Secondary Outcome:

    • CoGNIT [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Computerized neuropsychological test battery
    • 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
    • EuroQoL 5D5L [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Quality of life assessment
    • Urogenital Distress Inventory (UDI-6) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Continence assessment scale
    • Incontinence Impact Questionnaire, Short Form (IIQ-7) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Continence assessment scale
    • Barthel Index [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Activities of daily living assessment scale
    • Modified Rankin scale [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Disability assessment scale
    • Geriatric depression scale (GDS-15) [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Geriatric depression scale
    • MMSE [ Time Frame: baseline (before surgery) and 3 months after surgery ]
      Minimental state exam score


    Information By: Umeå University

    Dates:
    Date Received: December 13, 2016
    Date Started: March 2017
    Date Completion: February 2019
    Last Updated: March 13, 2017
    Last Verified: November 2016