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

This is a randomized, placebo controlled trial of shunt surgery for the treatment of idiopathic normal pressure hydrocephalus (INPH), a disorder affecting persons over age 60 years.  Patients are eligible if, after standard clinical testing of response to spinal fluid drainage, they have been identified as a candidate for treatment with surgical insertion of a ventriculo-peritoneal shunt (VP shunt). Patients who enroll will be in a 12 month study.  Baseline evaluations will include gait assessment, MRI scans, neuropsychology testing, and completion of additional questionnaires. At the time of surgery, half of patients will be randomly assigned to an adjustable shunt with a functional valve setting and half will be assigned to an adjustable shunt at the "virtual off" setting.  After 3 months and completion of reassessment, the shunts of all patients will be adjusted to a functional setting.  Follow-up evaluations will continue through the remaining 9 months of the study (6, 9, and 12 months after shunt insertion).

The primary outcome is change in walking speed (gait velocity). We will also look for change in neuropsychology tests results, MRI scans, and the responses to other questionnaires.


Principal Investigator(s)
Award Info

Johns Hopkins University/NIH