A Placebo-Controlled Effectiveness in INPH Shunting (PENS) Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Idiopathic Normal Pressure Hydrocephalus (INPH)

In brief

The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.

Key facts

Study ID

NCT03350750

Run by

Johns Hopkins University

People needed

18

Starts

2018-05-21

Expected to finish

2021-05-18

Last updated by the study team

2022-08-02

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 60 years; and
• Diagnosis of INPH based on the Investigator's clinical judgement based on criteria and testing as described in the INPH Guidelines; and
• Evans Ratio ≥ 0.30; and
• One positive supplementary test to include large volume Lumbar Puncture or extended CSF drainage per institutional standards; and
• 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
• 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, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.

You may not qualify if…

• Unable to walk 10 meters with or without an assistive device; or
• Baseline fastest gait velocity>1 m/sec and fastest gait velocity improvement is ≤ 30% with or without an assistive device; or
• Unable to return to the study center for follow up evaluation and shunt programming; or
• Participant is not medically cleared for shunt surgery per local standards; or
• 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
• Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus; or
• Previous intracranial neurosurgical procedure; or
• Current treatment with anticoagulation medications or expected to be on anticoagulation medications in future based on clinician evaluation; or
• Symptomatic cerebral or cerebellar infarction within 6 months from screening(asymptomatic lacunar infarctions are permitted); or
• Diagnosis of Parkinsonian syndrome that, in the investigator's judgment, will complicate the outcome evaluation; or
• Diagnosis of schizophrenia or any psychiatric diagnosis (including depression) that in the investigator's judgment will complicate the outcome evaluation (such as neuroleptic treatment for schizophrenia); or
• Diagnosis of dementia disorder where the investigator considers cognition deficit limits participation in the study; or
• Conditions impairing gait that are considered to be unrelated to hydrocephalus, such as hemiparesis, spasticity, cerebellar ataxia or musculoskeletal and joint disease.

Where it is running

• Johns Hopkins Medicine — Baltimore, Maryland, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Washington Medical Center — Seattle, Washington, United States
• University of Calgary — Calgary, Alberta, Canada
• Vancouver General Hospital/University of British Colombia — Vancouver, British Colombia, Canada
• Umeå University — Umeå, Sweden

Full record on ClinicalTrials.gov

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