Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Patients 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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
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Idiopathic Normal Pressure Hydrocephalus (iNPH) Cohort
Elderly patients aged 60 years or older presenting with clinical suspicion of the iNPH symptom triad (gait disturbance, cognitive impairment, and/or urinary dysfunction) and neuroimaging-confirmed ventriculomegaly. All participants undergo baseline clinical and cognitive assessments, preoperative neuroimaging evaluation using the iNPH Radscale (scores 0-12), and a standardized cerebrospinal fluid (CSF) tap test with 30-50 mL removal via lumbar puncture. Patients who proceed to clinically indicated ventriculoperitoneal (VP) shunt surgery (PS Medical medium-pressure valve, Medtronic) are followed prospectively at 1, 3, and 6 months postoperatively to assess functional outcomes and gait recovery. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change from Baseline in Hellström iNPH Scale Gait Domain Score at 6 Months
Časové okno: Baseline and 6 months postoperatively
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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. |
Baseline and 6 months postoperatively
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Predicting NPH Shunt Response
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