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

Brief description of study

This is a multicenter, randomized, blinded, placebo-controlled study of patients with suspected idiopathic normal pressure hydrocephalus (iNPH). The purpose of this study is to evaluate how well cerebrospinal fluid (CSF) shunt systems work in decreasing the symptoms of hydrocephalus. Individual participation in the study is anticipated to last up to 15 months.

Patients who present to clinic for NPH assessment will be screened and evaluated for inclusion and exclusion criteria. Participants who meet all prescreening criteria will be approached to sign the pre-consent for CSF collection. Participants who sign the pre-consent will have 10 mL CSF collected during their standard lumbar puncture or extended lumbar drainage to determine clinical benefit of CSF shunting for the participant as part of the screening process. If symptoms are improved following CSF drainage, the participant will be referred to the neurosurgeon to discuss the trial.

Clinical Study Identifier: s22-00487
ClinicalTrials.gov Identifier: NCT05081128
Principal Investigator: Jeffrey H Wisoff.
Other Investigator: James B Golomb.

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