A Randomized Cross-over Study for Normal Pressure Hydrocephalus

NCT01798641 | Completed Results

• 1 other identifier: NA_00042178
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Hydrocephalus; Cross-over

Outcome Measures

Primary Outcomes (5)

• Tinetti Score on Open Shunt vs. Closed Shunt

  The Tinetti tool test measures walking and balance. It is designed to determine an elders risk for falls within the next year. It takes about 8-10 minutes to complete. The patient is asked to complete the gait portion first with the evaluator walking close behind the elder and evaluating gait steppage and drift. The patient is then asked to complete the balance portion with the evaluator again standing close by the patient (towards the right and in front). The patient is then asked to sit and the score is then totaled.The higher the score, the better the performance. Scoring is done on a three point scale with a range on each item of 0-2 with 0 representing the most impairment. Individual scores are then combined to form three scales: a Gait Scale, a Balance Scale and then and overall Gait and Balance score. The maximum score for gait is 12 points while the maximum for Balance is 16 points with a total maximum for the overall score of 28 points.

  6 weeks

• Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt

  The TUG evaluation measures walking and balance. The patient is timed while they rise from an arm chair (approximate seat height 46 cm), walk at a comfortable and safe pace to a line on the floor three meters away, turn and walk back to the chair and sit down again. The patient walks through the test once before being timed to become familiar with the test. The subject wears his regular footwear and uses a walking aid (cane or walker) if necessary. A faster time indicates a better functional performance and a score of ≥13.5 seconds is used as a cut-point to identify those at increased risk of falls.

  6 weeks

• Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt

  The MCV gait grade evaluation measures balance and walking. The score ranges from 1 to 6 with higher values suggesting worse gait performance.

  6 weeks

• Kiefer Score on Open Shunt vs. Closed Shunt

  The Kiefer is a modified clinical grading tool that measures the severity of the three key symptoms (mental deficits, gait disturbance, incontinence) and two additional minor symptoms (headache and dizziness). The overall score may reach values between 0 and 24, with higher scores indicating more severe impairment

  6 weeks

• Kubo Score on Open Shunt vs. Closed Shunt

  The Kubo tool measures your symptoms in three categories: cognitive (attention and memory), gait/balance and urinary function.The score ranges from 0 to 24 with higher scores indicating worse symptoms

  6 weeks

Study Arms (2)

Open Shunt

EXPERIMENTAL

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

Device: MIETHKE proGAV® / MIETHKE proSA®

Closed Shunt

PLACEBO COMPARATOR

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

Device: MIETHKE proGAV® / MIETHKE proSA®

Interventions

MIETHKE proGAV® / MIETHKE proSA® DEVICE

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.

Closed Shunt; Open Shunt

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of Patients ( between 60 to 85 years old)
• Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait impairment
• Informed consent from patient

You may not qualify if:

• Etiology for hydrocephalus other than idiopathic normal pressure hydrocephalus
• Patients not capable of providing an informed consent.
• History of intra-cerebral hemorrhage
• Cardiac Pacemaker

Sponsors & Collaborators

• Johns Hopkins University: lead
• Aesculap, Inc.: collaborator
• Ohio State University: collaborator
• Rhode Island Hospital: collaborator
• Virginia Commonwealth University: collaborator
• Henry Ford Health System: collaborator

Study Sites (5)

Johns Hopkins University

Baltimore, Maryland, 21284, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Virgina Commonwealth University

Richmond, Virginia, 23220, United States

Location

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure; Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Daniele Rigamonti, MD FACS
• Organization: Johns Hopkins University

hydrocephalus@jhmi.edu

410-955-2259

Study Officials

• Daniele Rigamonti, MD FACS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Jennifer Lu

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 26, 2013
• Study Start: January 1, 2013
• Primary Completion: September 14, 2017
• Study Completion: September 14, 2017
• Last Updated: November 2, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-10

Locations

US (5)