NCT03076723

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hydrocephalus, Normal Pressure

Interventions

Type	Name	Description
OTHER	Change in shunt opening pressure	An individually determined change in shunt opening pressure is compared to no change in opening pressure.
OTHER	Simulated change in shunt opening pressure	The shunt opening pressure is reset to the same setting.

Timeline

• Start date: 2017-06-13
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-03-10
• Last updated: 2022-05-23

Locations

5 sites across 2 countries: Finland, Sweden