A Randomized Cross-over Study for Normal Pressure Hydrocephalus
Condition: Normal Pressure Hydrocephalus
MeSH terms: Hydrocephalus; Hydrocephalus, Normal Pressure
Study type: Interventional

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.
    

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.
    

Intervention name(s): MIETHKE proGAV® / MIETHKE proSA®
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hydrocephalus; Cross-over