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
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.
|Condition or disease||Intervention/treatment||Phase|
|Hydrocephalus, Normal Pressure||Other: Change in shunt opening pressure Other: Simulated change in shunt opening pressure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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)
- 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)
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
|Kuopio university hospital|
|Kuopio, Finland, 70210|
|Turku university hospital|
|Turku, Finland, 20521|
|Sahlgrenska university hospital|
|Gothenburg, Sweden, 41345|
|Umeå university hospital|
|Umeå, Sweden, 90185|
|The Uppsala university hospital|
|Uppsala, Sweden, 75185|
|Principal Investigator:||Jan Malm, MD, PhD||Umeå University Hospital|
|Study Director:||Sara Qvarlander, PhD||Umeå University|