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A Randomized Cross-over Study for Normal Pressure Hydrocephalus

NCT01798641 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-11-02

Study results available
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Summary

The goal of our study is to verify the effectiveness of the shunt and to identify the most sensitive criteria to select patients for surgery. The study is designed to assess improvement in walking and balance (gait), urinary function and memory after shunting. In addition, the study aims to identify the most accurate and sensitive tools to measure improvement for our patients.

Conditions

  • Normal Pressure Hydrocephalus

Interventions

DEVICE

MIETHKE proGAV® / MIETHKE proSA®

The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open.

Sponsors & Collaborators

  • Aesculap, Inc.

    collaborator INDUSTRY

  • Ohio State University

    collaborator OTHER

  • Rhode Island Hospital

    collaborator OTHER

  • Virginia Commonwealth University

    collaborator OTHER

  • Henry Ford Health System

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Daniele Rigamonti, MD FACS · Johns Hopkins University

  • Jennifer Lu · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-09-14
Completion
2017-09-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01798641 on ClinicalTrials.gov