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CSF Shunt Surgery for Normal Pressure Hydrocephalus (PENS Trial)
PENS Trial Summary
This trial is testing whether a CSF shunt surgery is effective in iNPH patients. The trial is blinded, meaning the patients do not know if they are receiving the surgery or a placebo, and it is randomized, meaning the patients are randomly assigned to either group.
PENS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPENS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.PENS Trial Design
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Who is running the clinical trial?
Media Library
- I have had a positive result from a major spinal fluid test.My Parkinson's symptoms may affect the trial's results, as judged by a doctor.I have had surgery or procedures for water on the brain.I have had trouble walking properly for at least 6 months.I have been diagnosed with iNPH and recommended for shunt surgery.I cannot walk 10 meters even with help.I cannot return to the study center for follow-up visits or adjustments.I have a condition unrelated to hydrocephalus that affects my ability to walk.I can walk faster than 1 meter per second and my walking speed hasn't improved by 30% even with help.I have not had a stroke affecting my brain in the last 6 months.I have secondary NPH due to a recent brain condition or injury.I am not approved for shunt surgery according to local health standards.I can follow instructions and report my experiences for the trial.I am 60 years old or older.I have had brain surgery before.
- Group 1: Open Shunt Group
- Group 2: Closed Shunt Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there numerous US-based medical centers running this clinical research?
"University of Calgary, University of South Florida, and Cleveland Clinic are three areas that have been enlisted to help recruit patients for this medical study. Additionally, there are 17 additional sites being used in the recruitment process."
What is the participant recruitment rate for this experiment?
"Affirmative. According to records on clinicaltrials.gov, this medical trial is presently recruiting patients and has done so since May 18th 2022. The study, which was last revised on November 4th 2022, seeks 100 participants across 17 different sites."
Is recruitment ongoing for this clinical trial?
"Clinicialtrials.gov indicates that this study is actively seeking participants, with the trial having first been made available to the public on May 18th 2022 and most recently updated on November 4th 2022."
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