NCT03350750

A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial

A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial: Proof of Concept

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.

Detailed description

The primary intervention will be setting the FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve to active (open shunt group)(setting 4)(110 mm H2O) or placebo (closed shunt group)(setting 8)(\>400 mm H2O)in a 1:1 ratio. By the time of the primary objective evaluation at four months, the closed shunt group will have zero months of active treatment, and the open shunt group will have four months of active treatment. At four months, shunts for subjects in the closed shunt group will be adjusted to setting 4. To maintain blinding, all patients will be adjusted/ mock adjusted to the active setting in a similar fashion. Patients from both groups will not be adjusted before four months of active treatment, unless judged medically necessary by the treating team. Following four months of active treatment, all subjects in each group will have shunt adjustments according to clinical standards at each center.

Conditions

• Idiopathic Normal Pressure Hydrocephalus (INPH)

Interventions

Type	Name	Description
DEVICE	programmable CSF shunt valve	Brain shunt surgery using a programmable CSF shunt valve

Timeline

• Start date: 2018-05-21
• Primary completion: 2021-03-19
• Completion: 2021-05-18
• First posted: 2017-11-22
• Last updated: 2022-08-02
• Results posted: 2022-05-27

Locations

7 sites across 3 countries: United States, Canada, Sweden

Regulatory

• FDA-regulated device study