Efficacy in iNPH Shunting (PENS) Trial (PENS)

J
Jesse Savage, MD

Primary Investigator

Enrolling By Invitation
60 years and older
All
Phase N/A
100 participants needed
1 Location

Brief description of study

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

Detailed description of study

The primary intervention will be setting the FDA-approved Certas Plus with Siphonguard,grammable CSF shunt valve to active (open shunt group)(setting 4)(110 mm H2O) or placebo (closed shunt group)(setting 8)(>400 mm H2O)in a 1:1 ratio. By the time of the primarybjective evaluation at three months, the closed shunt group will have zero months of actived the open shunt group will have three months of active treatment. At threehs, shunts for subjects in the closed shunt group will be adjusted to setting 4. Toblinding, all patients will be adjusted / mock adjusted to the active setting in ahion. Patients from both groups will not be adjusted before three months of activeunless judged medically necessary by the treating team. Following the three month visit, all subjects in each group will have shunt adjustments according to clinical standardsh center.

Eligibility of study

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

  • Conditions: Idiopathic Normal Pressure Hydrocephalus (INPH)
  • Age: 60 Years
  • Gender: All

Inclusion Criteria:
  1. Age ≥ 60 years; and
  2. Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator'sjudgement based on criteria and testing as described in the iNPH Guidelines;
  3. Evans Ratio ≥ 0.30; and
  4. One positive supplementary test to include either large volume Lumbar Puncture orded 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 ≥ 6hs; and
  6. Participant has the sensory motor skills, communication skills and understanding toy with the testing and reporting required in the PENS trial; and
  7. Participant is able to give written informed consent.
Exclusion Criteria:
  1. Unable to walk 10 meters with or without an assistive device; or
  2. Baseline fastest gait velocity (out of three gait trials) >1 m/sec prior to drainaged fastest gait velocity improvement is < 30% with or without an assistivedevice; or
  3. Unable to return to the study center for follow up evaluation and shunt programming;
  4. Participant is not medically cleared for shunt surgery per local standards; or
  5. Secondary NPH. (Prior encephalitis, meningitis, subarachnoid hemorrhage, traumaticbrain injury (including concussion) within two years or with brain injury or skullure 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 surgicalvention for hydrocephalus; or
  7. Previous intracranial neurosurgical procedure; or
  8. Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening(asymptomatic lacunar infarctions are permitted); or
  9. Diagnosis of Parkinsonian syndrome that, in the investigator's judgment, willhe outcome evaluation; or
  10. Diagnosis of schizophrenia or any psychiatric diagnosis (including depression) that,he investigator's judgment, will complicate the outcome evaluation (such asuroleptic treatment for schizophrenia); or
  11. Diagnosis of dementia disorder where the investigator considers cognition deficithe study; or
  12. Conditions impairing gait that are considered to be unrelated to hydrocephalus, suchhemiparesis, spasticity, cerebellar ataxia or musculoskeletal and joint disease,which will interfere with gait assessment or the potential for gait improvement.
  13. Individuals with contraindication to MRI (e.g., implanted electric and electronicdevices, aneurysm clip(s), any metallic fragment or foreign body, coronary andheral artery stents, cardiac pacemaker, known claustrophobia, or known/possiblegnancy or breast-feeding) will be excluded according to institutional guidelines.

Updated on 01 Aug 2024. Study ID: IRB00305245
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