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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study 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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
|---|
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and 6 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Predicting NPH Shunt Response
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