Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Patients Using Radscale and Lumbar Puncture
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change from Baseline in Hellström iNPH Scale Gait Domain Score at 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
结局指标
主要结局
Change from Baseline in Hellström iNPH Scale Gait Domain Score at 6 Months
时间窗: 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.
次要结局
未报告次要终点
研究者
Hassan Mohamed Hani Thabet
Resident of Neurosurgery
Assiut University