NCT03350750|CompletedResultsDMCFDA Device
A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial
PENS
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Sponsor study identifier
interventional
18
3 countries
7
Study Start
May 21, 2018
Actual (reported)Primary Completion
March 19, 2021
Actual (reported)Study Completion
May 18, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 18, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 14, 2017
Actual (reported)November 22, 2017
Actual (reported)May 21, 2018
Actual (reported)March 19, 2021
Actual (reported)May 18, 2021
Actual (reported)May 27, 2022
Actual (reported)Change in Gait Velocity
Evaluation of CSF shunting in Idiopathic Normal Pressure Hydrocephalus (INPH) patients through a group comparison of improvement from baseline at four months between active and placebo-controlled groups, using the primary endpoint of gait velocity in meters per second (m/s).
Baseline and 4 months
Change in Cognition as Assessed by the Montreal Cognitive Assessment (MoCA) Score
Baseline and 4 Months
Change in Bladder Control as Assessed by the Overactive Bladder Questionnaire, Short Form
Baseline and 4 months
Change in Function as Assessed by the Lawton Activities of Daily Living/Independence in Activities of Daily Living (ADL/IADL) Test Score
Baseline and 4 months
Change in Function as Assessed by the Modified Rankin Scale (MRS)
Baseline and 4 months
Change in Cognition as Assessed by the Symbol Digit Modalities Test (SDMT)
Baseline and 4 months
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
Brain shunt surgery using a programmable CSF shunt valve
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
University of New Mexico
Albuquerque, New Mexico, 87106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Washington Medical Center
Seattle, Washington, 98196, United States
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
Vancouver General Hospital/University of British Colombia
Vancouver, British Colombia, V5Z 1M9, Canada
Umeå University
Umeå, Sweden
Luciano M, Holubkov R, Williams MA, Malm J, Nagel S, Moghekar A, Eklund A, Zwimpfer T, Katzen H, Hanley DF, Hamilton MG; PENS Co-investigators and AHCRN Site PIs. Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial. Neurosurgery. 2023 Mar 1;92(3):481-489. doi: 10.1227/neu.0000000000002225. Epub 2022 Nov 25.
Mark Luciano, MD
Johns Hopkins University
18 participants (actual enrollment reported by the registry).
First Submitted
November 14, 2017
First Posted
November 22, 2017
Change in Cognition and Frailty After Shunt Surgery in Idiopathic Normal Pressure Hydrocephalus (iNPH)
Contact the study team to confirm eligibility.
Study Start
May 21, 2018
Actual (reported)Primary Completion
March 19, 2021
Actual (reported)Study Completion
May 18, 2021
Actual (reported)Last Updated
August 2, 2022
Results First Posted
May 27, 2022
Record last verified: 2022-05
After subject enrollment and follow up have been completed, the Data Coordinating Center (DCC) of the study will prepare a final study database for analysis. A releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be re-coded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional identifiers. The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. In accordance with policies determined by the investigators and funding sponsors, the releasable database will be provided to users in electronic form.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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