Trial record 15 of 34 for:    Normal Pressure Hydrocephalus

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Johns Hopkins University
Sponsor:
Collaborators:
Aesculap, Inc.
Ohio State University
Rhode Island Hospital
Virginia Commonwealth University
Information provided by (Responsible Party):
Daniele Rigamonti, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01798641
First received: January 31, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention
Normal Pressure Hydrocephalus
Device: MIETHKE proGAV® / MIETHKE proSA®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Shunt Surgery in Normal Pressure Hydrocephalus: a Randomized Cross-over Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Difference in Tinetti score on optimal vs. sub optimal drainage [ Time Frame: 6 week follow-up on treatment arms ] [ Designated as safety issue: Yes ]
    The Tinnetti tool test measures walking and balance.

  • Difference in Timed Up and Go (TUG) score on optimal vs. sub optimal drainage [ Time Frame: 6 week follow-up on treatment arm ] [ Designated as safety issue: Yes ]
    The TUG evaluation measures walking and balance.

  • Difference in MCV Gait Grade on optimal vs. sub optimal drainage [ Time Frame: 6 week follow-up at treatment arm ] [ Designated as safety issue: Yes ]
    The MCV gait grade evaluation measures balance and walking.

  • Difference in Kiefer score on optimal vs. sub optimal drainage [ Time Frame: 6 week follow-up on treatment arms ] [ Designated as safety issue: No ]
    The Kiefer is a modified clinical grading tool that measures the severity of your symptoms in five domains: gait/balance, mental, urinary function,headache, dizziness.

  • Difference in Kudo score on optimal vs. sub optimal drainage [ Time Frame: 6 week follow-up on treatment arms ] [ Designated as safety issue: No ]
    The Kudo tool measures your symptoms in three categories: cognitive (attention and memory), gait/balance and urinary function.


Estimated Enrollment: 48
Study Start Date: January 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01798641

Contacts
Contact: Jamie Hoffberger, MA 443-287-3648 hydrocephalus@jhmi.edu
Contact: Daniele Rigamonti, MD FACS 410-955-2259 hydrocephalus@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21284
Contact: Jamie Hoffberger, MA    443-287-3648    hydrocephalus@jhmi.edu   
Contact: Daniele Rigamonti, MD FACS    410-955-2259    hydrocephalus@jhmi.edu   
United States, Ohio
Ohio State University Not yet recruiting
Columbus, Ohio, United States, 43210
United States, Rhode Island
Rhode Island Hospital Not yet recruiting
Providence, Rhode Island, United States, 02903
United States, Virginia
Virgina Commonwealth University Not yet recruiting
Richmond, Virginia, United States, 23220
Sponsors and Collaborators
Johns Hopkins University
Aesculap, Inc.
Ohio State University
Rhode Island Hospital
Virginia Commonwealth University
Investigators
Principal Investigator: Daniele Rigamonti, MD FACS Johns Hopkins University
Study Director: Jamie Hoffberger, MA Johns Hopkins University
  More Information

No publications provided

Responsible Party: Daniele Rigamonti, MD FACS, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01798641     History of Changes
Other Study ID Numbers: NA_00042178
Study First Received: January 31, 2013
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Hydrocephalus
Cross-over

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hypertension

ClinicalTrials.gov processed this record on July 28, 2014