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A Randomized Cross-over Study for Normal Pressure Hydrocephalus (ARCS NPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798641
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Aesculap, Inc.
Ohio State University
Rhode Island Hospital
Virginia Commonwealth University
Henry Ford Health System
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Normal Pressure Hydrocephalus Device: MIETHKE proGAV® / MIETHKE proSA® Not Applicable

Detailed Description:

Normal Pressure Hydrocephalus (NPH) causes memory loss, walking, and urinary difficulties. If NPH goes unidentified and untreated it can cause severe disability. The cause of this disease is poorly understood. It may involve damage caused by impaired blood flow in the brain.

The standard methods by which we diagnose patients who have symptoms of NPH are less accurate than desired. Many times patients remain undiagnosed or untreated while others receive treatment due to a false-positive diagnosis.

To treat NPH, a small tube called a 'shunt' can be surgically placed in the brain to drain cerebrospinal fluid (CSF) and help relieve symptoms. Currently, the reported response rates to shunting vary from 31% to 89%. Follow-up studies have shown that the shunts may not work long-term. This could be due to the natural history of the disease, development of other diseases, or due to a short term 'placebo effect' following the shunt placement surgery.

Our group is doing a study of patients with NPH. All participants in this study will have a shunt placed. These shunts are programmable and, once placed, may be opened or closed by the doctor. Programming the shunt does not require an additional surgical procedure. All study participants will be divided into two groups. One group will have their shunts open and draining. The other group will have their shunts closed (not draining). After 6 weeks, the groups will be switched. Those with open shunts will have them closed, and the group with closed, non-draining shunts, will have theirs opened. Participants will not know if their shunts are open (draining) or if they are closed (not draining). Study participants will be followed for two years. Any participants who develop recurrent, new or worsening symptoms will be taken off study and treated according to good medical practice.

The purpose of this study is to (a) look for symptom improvement in response to the draining shunt compared to the non-draining shunt (placebo affect), (b) find 'predictors' that will help doctors identify patients who will respond well to shunt placement, (c) monitor the long-term effects of these shunts, and (d) assess current diagnostic testing to see which methods are most accurate.

Eligibility Criteria:

Inclusion Criteria

  1. Age of Patients ( between 60 to 85 years old).
  2. Clinically suspected Idiopathic Normal Pressure Hydrocephalus (iNPH) with at least gait impairment.
  3. Informed consent from patient.

Exclusion Criteria

  1. Etiology for hydrocephalus other than iNPH.
  2. Patients not capable of providing an informed consent.
  3. History of intra-cerebral hemorrhage.
  4. Cardiac Pacemaker.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Shunt Surgery in Normal Pressure Hydrocephalus: a Randomized Cross-over Study
Study Start Date : January 2013
Actual Primary Completion Date : September 14, 2017
Actual Study Completion Date : September 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hydrocephalus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Shunt
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®
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.
Placebo Comparator: Closed Shunt
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®
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.


Outcome Measures
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Primary Outcome Measures :
  1. Tinetti Score on Open Shunt vs. Closed Shunt [ Time Frame: 6 weeks ]
    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.

  2. Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt [ Time Frame: 6 weeks ]
    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.

  3. Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt [ Time Frame: 6 weeks ]
    The MCV gait grade evaluation measures balance and walking. The score ranges from 1 to 6 with higher values suggesting worse gait performance.

  4. Kiefer Score on Open Shunt vs. Closed Shunt [ Time Frame: 6 weeks ]
    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

  5. Kubo Score on Open Shunt vs. Closed Shunt [ Time Frame: 6 weeks ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798641


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21284
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Virginia
Virgina Commonwealth University
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Johns Hopkins University
Aesculap, Inc.
Ohio State University
Rhode Island Hospital
Virginia Commonwealth University
Henry Ford Health System
Investigators
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Principal Investigator: Daniele Rigamonti, MD FACS Johns Hopkins University
Study Director: Jennifer Lu Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
Study Protocol and Statistical Analysis Plan  [PDF] March 19, 2013

More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01798641    
Other Study ID Numbers: NA_00042178
First Posted: February 26, 2013    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018
Last Verified: October 2018
Keywords provided by Johns Hopkins University:
Hydrocephalus
Cross-over
Additional relevant MeSH terms:
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Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases