A Placebo-Controlled Efficacy in iNPH Shunting (PENS) Trial

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Idiopathic Normal Pressure Hydrocephalus
  • Age: Between 60 Year(s) - 110 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Diagnosis of iNPH and recommendation for shunt surgery.
    2. History or evidence of gait impairment with a duration of 6 months.
    3. Participant has the sensory motor skills, communication skills and understanding to comply with the testing and reporting required in the PENS trial.
    4. Participant is able to give written informed consent.

You may not be eligible for this study if the following are true:

    1. Unable to walk 10 meters with or without an assistive device.
    2. Unable to return to the study center for follow up evaluation and shunt programming.
    3. Participant is not medically cleared for shunt surgery per local standards.
    4. Secondary NPH. (Prior encephalitis, meningitis, subarachnoid hemorrhage, traumatic brain injury (including concussion) within two years or with brain injury or skull fracture on baseline imaging, brain abscess, brain tumor, obstructive hydrocephalus (including acquired aqueductal stenosis and carcinomatous meningitis).
    5. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus including lumbar CSF shunting.
    6. Previous intracranial neurosurgical procedure.
    7. Current treatment with anticoagulation medications or expected to be on anti- coagulation medications in future based on clinician evaluation.
    8. Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening.
    9. Diagnosis of Parkinsonian syndrome that will impede the outcome evaluation.
    10. Diagnosis of schizophrenia or any psychiatric diagnosis (including depression) that will impede the outcome evaluation.
    11. Diagnosis of dementia disorder where the investigator considers cognition deficit limits participation in the study.
    12. Conditions impairing gait that are considered to be unrelated to hydrocephalus, such as hemiparesis, spasticity, cerebellar ataxia or musculoskeletal and joint disease, which will interfere with gait assessment or the potential for gait improvement.

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