N/A
N=38
A Randomized Cross-over Study for Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Bottom Line
View on ClinicalTrials.gov: NCT01798641 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Tinetti Score on Open Shunt vs. Closed Shunt — 24.50; 26.50 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MIETHKE proGAV® / MIETHKE proSA® (Device)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinetti Score on Open Shunt vs. Closed Shunt |
24.50; 26.50 | — |
| PRIMARY Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt |
12.0; 10.5 | — |
| PRIMARY Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt |
3.00; 1.50 | — |
| PRIMARY Kiefer Score on Open Shunt vs. Closed Shunt |
4; 5 | — |
| PRIMARY Kubo Score on Open Shunt vs. Closed Shunt |
3; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age of Patients ( between 60 to 85 years old)
- Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait impairment
- Informed consent from patient
Exclusion Criteria
- Etiology for hydrocephalus other than idiopathic normal pressure hydrocephalus
- Patients not capable of providing an informed consent.
- History of intra-cerebral hemorrhage
- Cardiac Pacemaker
Data sourced from ClinicalTrials.gov (NCT01798641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.