NCT05081128

Efficacy in iNPH Shunting (PENS) Trial

A Placebo-Controlled Efficacy in iNPH Shunting (PENS) Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The Placebo-Controlled Efficacy 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 efficacy 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 three months, the closed shunt group will have zero months of active treatment, and the open shunt group will have three months of active treatment. At three 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 three months of active treatment, unless judged medically necessary by the treating team. Following the three month visit, 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: 2022-05-18
• Primary completion: 2027-05-01
• Completion: 2027-08-01
• First posted: 2021-10-18
• Last updated: 2025-05-08

Locations

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

Regulatory

• FDA-regulated device study