Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture

Idiopathic normal pressure hydrocephalus (iNPH) is a neurological disorder in older adults characterized by walking difficulties, cognitive decline, and urinary dysfunction. While ventriculoperitoneal (VP) shunt surgery can relieve symptoms, identifying which patients will experience meaningful recovery remains challenging.

The purpose of this study is to determine how accurately two preoperative diagnostic tools, the iNPH Radscale (a structured brain imaging score) and a standardized cerebrospinal fluid (CSF) tap test (lumbar puncture), predict symptom and gait improvement following shunt surgery.

Participants enrolled in this study will undergo:

* Baseline neurological evaluations, cognitive screening via the Mini-Mental State Examination, and standardized walking tests (Timed Up and Go and 10-meter walk tests). * Review of brain CT or MRI scans using the 7-feature iNPH Radscale (scored 0 to 12). * A standardized CSF tap test, involving the removal of 30 to 50 mL of spinal fluid via lumbar puncture, followed by repeat walking evaluations at 2-4 hours and 24 hours to monitor temporary symptom response. * Standard-of-care VP shunt surgery if determined clinically appropriate by the treating surgical team. * Postoperative follow-up visits at 1, 3, and 6 months to evaluate functional recovery and gait changes using the Hellström iNPH scale.

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Key information

Conditions

Idiopathic Normal Pressure Hydrocephalus Brain Diseases Central Nervous System Diseases Hydrocephalus Hydrocephalus, Normal Pressure Mobility Limitation Nervous System Diseases Normal Pressure Hydrocephalus Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 60 years or older.
Clinical suspicion of idiopathic normal pressure hydrocephalus (iNPH), including the clinical triad (gait disturbance, cognitive impairment, and/or urinary dysfunction).
Neuroimaging (brain CT or MRI) demonstrating ventriculomegaly compatible with possible iNPH.
Physical ability to perform standardized gait testing.
Ability to provide written informed consent, or consent provided via a legally authorized representative.

Exclusion criteria

Secondary hydrocephalus with an identifiable alternative cause (e.g., recent subarachnoid or intraventricular hemorrhage, major head trauma, or central nervous system infection).
Presence of any contraindication to lumbar puncture (including relevant bleeding risk/coagulopathy, puncture-site infection, or intracranial mass effect).
Previous cerebrospinal fluid (CSF) shunt or definitive hydrocephalus surgical intervention prior to enrollment.
Concurrent acute illness preventing valid clinical or functional assessment.

Treatment and study plan

Primary outcomes

Change from Baseline in Hellström iNPH Scale Gait Domain Score at 6 Months

Time frame: Baseline and 6 months postoperatively

The Hellström idiopathic normal pressure hydrocephalus (iNPH) scale gait domain assesses walking speed, step count during a standardized 10-meter walk test, and ordinal rating of gait pattern. Scores are converted to a normalized scale ranging from 0 to 100, where 0 represents the most severe gait dysfunction and 100 represents normal performance of healthy individuals. Higher scores or positive changes from baseline indicate clinical improvement in gait function.

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Patients Using Radscale and Lumbar Puncture

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 22, 2026
Registry last updated: Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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