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Efficacy in iNPH Shunting (PENS) Trial

Participate in a trial to understand shunt effectiveness for iNPH.

Recruiting
60 years and older
All
Phase N/A

Study Purpose: This study is testing a type of surgery called shunt surgery for people with Idiopathic Normal Pressure Hydrocephalus (iNPH), a condition where extra fluid builds up in the brain causing walking problems, memory loss, and trouble controlling urination. The surgery involves placing a small tube called a shunt to drain the extra fluid.

Trial Design: Participants will either have the shunt turned on (active) or off (placebo) for three months. After three months, all shunts will be set to active. This helps doctors see if the shunt is really helping. The study is blinded, meaning participants and doctors don't know who has the active shunt initially.

  • Duration: Study lasts three months before first shunt adjustment.
  • Eligibility: Must be 60 or older, diagnosed with iNPH, and able to walk.
  • Risks: Standard surgical risks plus potential for shunt malfunction.

Note: Participants need to be able to return to the study center for follow-ups. If you have certain conditions like Parkinson’s or schizophrenia, you may not be eligible. This study does not offer compensation.

Study details
    Idiopathic Normal Pressure Hydrocephalus (INPH)

NCT05081128

Johns Hopkins University

11 January 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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