Completed

ARCS NPHShunt Surgery Efficacy in Normal Pressure Hydrocephalus

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What is being tested

MIETHKE proGAV® / MIETHKE proSA®

+ MIETHKE proGAV® / MIETHKE proSA®

Device
Who is being recruted

Brain Diseases+2

+ Central Nervous System Diseases

+ Nervous System Diseases

From 60 to 85 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorJohns Hopkins University
Last updated: November 2, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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 Age of Patients ( between 60 to 85 years old). Clinically suspected Idiopathic Normal Pressure Hydrocephalus (iNPH) with at least gait impairment. Informed consent from patient. Exclusion Criteria Etiology for hydrocephalus other than iNPH. Patients not capable of providing an informed consent. History of intra-cerebral hemorrhage. Cardiac Pacemaker.

Principal SponsorJohns Hopkins University
Last updated: November 2, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHydrocephalusHydrocephalus, Normal Pressure

Criteria

3 inclusion criteria required to participate
Age of Patients ( between 60 to 85 years old)

Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait impairment

Informed consent from patient

4 exclusion criteria prevent from participating
Cardiac Pacemaker

Etiology for hydrocephalus other than idiopathic normal pressure hydrocephalus

History of intra-cerebral hemorrhage

Patients not capable of providing an informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Johns Hopkins University

Baltimore, United StatesOpen Johns Hopkins University in Google Maps

Henry Ford Health System

Detroit, United States

Ohio State University

Columbus, United States

Rhode Island Hospital

Providence, United States
Completed5 Study Centers