Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Elderly patients aged 60 years or older presenting to the Department of Neurosurgery at Assiut University Hospitals with clinical suspicion of idiopathic normal pressure hydrocephalus (iNPH) characterized by the clinical triad of gait disturbance, cognitive impairment, and/or urinary dysfunction, alongside neuroimaging (CT or MRI) evidence of ventriculomegaly compatible with iNPH.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 1 trial groupGroup A: Idiopathic Normal Pressure Hydrocephalus (iNPH) Cohort
Trial outcomes
Primary outcomes
1
Change from Baseline in Hellström iNPH Scale Gait Domain Score at 6 Months
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.
Time frame
Baseline and 6 months postoperativelyLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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