Clinical Trial Title
PENS: A Placebo-Controlled Efficacy in iNPH ShuntingNational Clinical Trial Number:
NCT05081128Contact Information
Clinical Trial Protocol Description:
The PENS Trial, sponsored by the National Institute of Health, is evaluating if cerebrospinal fluid (CSF) shunting improves gait and other neurological symptoms in patients diagnosed with idiopathic normal pressure hydrocephalus.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are 60 years of age or older.
- Have a diagnosis of Idiopathic Normal Pressure Hydrocephalus (iNPH) and have been recommended for shunt surgery based on physician’s clinical judgment.
- Have a history of evidence of gait impairment (such as decreased step height or length, decreased speed) with a duration of ≥ 6 months.
- Have the sensory motor skills, communication skills and understanding to comply with the testing and reporting required in the PENS trial.
You will be excluded from the study if any of the following criteria apply to you:
- Are unable to walk 10 meters with or without assistive device
- Are unable to return to the study center for follow up evaluation and shunt programming.
- Have Secondary NPH, prior encephalitis, meningitis, subarachnoid hemorrhage, traumatic brain injury (including concussion).
- Have had previous intracranial neurosurgical procedure.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.
Study Details
Clinical Trial Investigator
Sepehr Sani, MD
Contact Information
Amanda Sremac
Clinical Trial Location
RUSH University Medical Center