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). Using FDA-approved technology, we propose a prospective randomized placebo-controlled clinical trial for the surgical shunting treatment of iNPH. These valve systems allow a well-maintained blinded placebo control because the surgical and adjustment procedures can be entirely identical in the active and placebo groups.
Clinical Study Identifier: s22-00487
ClinicalTrials.gov Identifier: NCT05081128
Principal Investigator:
David H Harter.
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