A Randomized Cross-over Study for Normal Pressure Hydrocephalus
A Randomized Cross-over Study for Normal Pressure Hydrocephalus
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.
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.
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