Clinical Trial: A Randomized Cross-over Study for Normal Pressure Hydrocephalus

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Shunt Surgery in Normal Pressure Hydrocephalus: a Randomized Cross-over Study

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.

Detailed Summary:

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 trea
Sponsor: Johns Hopkins University

Current Primary Outcome:

  • Difference in Tinetti score on optimal vs. sub optimal drainage [ Time Frame: 6 week follow-up on treatment arms ]
    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 ]
    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 ]
    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 ]
    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 ]
    The Kudo tool measures your symptoms in three categories: cognitive (attention and memory), gait/balance and urinary function.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Johns Hopkins University

Dates:
Date Received: January 31, 2013
Date Started: January 2013
Date Completion: August 2017
Last Updated: March 21, 2017
Last Verified: March 2017