PENS Pocket Card

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Primary Inclusion Criteria

1. Age ≥ 60 years; and
2. Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator’s clinical judgement using criteria and testing as described in the iNPH Guidelines; and
3. Evans Ratio ≥ 0.30; and
4. One positive supplementary test to include either large volume Lumbar Puncture or extended CSF drainage per institutional standards; and
5. History or evidence of gait impairment (such as decreased step height or length, decreased speed, retropulsion as described in the iNPH Guidelines) duration ≥ 6 months; and
6. Participant has the sensory motor skills, communication skills and understanding to comply with the testing and reporting required in the PENS trial; and Participant is able to give written informed consent. 

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Primary Exclusion Criteria

1. Unable to walk 10 meters with or without an assistive device; or
2. Screening fastest gait velocity > 1 m/sec prior to drainage trial unless the patient’s gait velocity improves > 30%; or
3. Unable to return to the study center for follow up evaluation and shunt programming; or
4. Participant is not medically cleared for shunt surgery per local standards; or
5. 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); or
6. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus including lumbar CSF shunting; or
7. Previous intracranial neurosurgical procedure; or
8. Current treatment with anticoagulation medications or expected to be on anti- coagulation medications in future based on clinician evaluation; or
9. Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening (asymptomatic lacunar infarctions are permitted); or
10. Diagnosis of Parkinsonian syndrome that, in the investigator’s judgment, will impede the outcome evaluation; or
11. Diagnosis of schizophrenia or any psychiatric diagnosis (including depression) that, in the investigator’s judgment, will impede the outcome evaluation (such as neuroleptic treatment for schizophrenia); or
12. Diagnosis of dementia disorder where the investigator considers cognition deficit limits participation in the study; or
13. 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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