Efficacy in iNPH Shunting (PENS) Trial

A vizsgálat adatai

Ki végzi

Johns Hopkins University

Azonosító

NCT05081128

A regiszteradat frissítve

2026. augusztus 27.

Eredeti leírás

The Placebo-Controlled Efficacy 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 efficacy in iNPH patients.A teljes eredeti leírásKevesebb

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

The Placebo-Controlled Efficacy 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 efficacy in iNPH patients.

Bevonási feltételek: Age ≥ 60 years; and; Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator's clinical judgement based on criteria and testing as described in the iNPH Guidelines; Evans Ratio ≥ 0.30; and; One positive supplementary test to include either 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.

Kizáró feltételek: Baseline fastest gait velocity (out of three gait trials) >1 m/sec prior to drainage trial and fastest gait velocity improvement is < 30% with or without an assistive device; 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; 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, which will interfere with gait assessment or the potential for gait improvement; Individuals with contraindication to MRI (e.g., implanted electric and electronic devices, aneurysm clip(s), any metallic fragment or foreign body, coronary and peripheral artery stents, cardiac pacemaker, known claustrophobia, or known/possible pregnancy or breast-feeding) will be excluded according to institutional guidelines; Unable to walk 10 meters with or without an assistive device; or; Unable to return to the study center for follow up evaluation and shunt programming; or; Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening (asymptomatic lacunar infarctions are permitted); or.

ClinicalTrials.gov NCT05081128