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The aim of this study is to determine the clinical spectrum and natural progression of idiopathic normal pressure hydrocephalus （iNPH ) and related disorders in a prospective single center study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the etiology and molecular mechanisms of these diseases.
Due to the heterogeneity of the etiology of idiopathic normal pressure hydrocephalus , almost all published studies on the clinical outcome and prognostic factors of iNPH are relatively limited, and most of them are retrospective. It is not clear which is the most reliable predictor of clinical outcome. Therefore, the researchers conducted this prospective cohort study to identify the occurrence, development and outcome of iNPH and determine the main prognostic factors through clinical scales, biomarkers and imaging.
At study visits a standardized clinical examination will be performed including application of clinical rating scales. At all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, CSF, and/or a muscle biopsy.
Optionally, additional examinations may be performed including imaging，such as DTIALPS, neurophysiological examination, analysis of patient or observer reported outcomes and analysis to characterize molecular biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrocephalus | high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS |
| |
| Normal group | Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocephalus group | Diagnostic Test | Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS |
| Measure | Description | Time Frame |
|---|---|---|
| DTIALPS | Change of DTIALPS singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed. | Change from Baseline at 6 months after VP shunt |
| Measure | Description | Time Frame |
|---|---|---|
| Kiefer score | A score for iNPH severity; range 0-26; higher indicates higher severity. | Change from Baseline at 6 months after VP shunt |
| Mini mental state Examination | A score for cognitive ability; range 0-30; higher indicates higher severity. |
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Inclusion Criteria:
Exclusion Criteria:
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patients who was diagnosed as idiopathic normal pressure hydrocephalus
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fengzeng jian, md | Contact | 01083198899 | jianfengzeng@xwh.ccmu.edu.cn | |
| xin qu, md | Contact | 01083198899 | xinqu@xwhosp.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fengzeng Jian | Recruiting | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37010581 | Background | Zhang C, Xu K, Zhang H, Sha J, Yang H, Zhao H, Chen N, Li K. Recovery of glymphatic system function in patients with temporal lobe epilepsy after surgery. Eur Radiol. 2023 Sep;33(9):6116-6123. doi: 10.1007/s00330-023-09588-y. Epub 2023 Apr 3. | |
| 37724800 | Background | Georgiopoulos C, Tisell A, Holmgren RT, Eleftheriou A, Rydja J, Lundin F, Tobieson L. Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging. J Neurosurg. 2023 Sep 8;140(3):612-620. doi: 10.3171/2023.6.JNS23260. Print 2024 Mar 1. |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy
| normal group | Other | Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS |
|
| Change from Baseline at 6 months after VP shunt |
| Gait evaluation | 10 meters walking test were evaluated of iNPH patients. | Change from Baseline at 6 months after VP shunt |
| modified Rankin scale | A score for functional neurological status ; range 0-5; higher indicates higher severity. | Change from Baseline at 6 months after VP shunt |
| Change in the resting state fMRI | Change of BOLD singal intensity in the resting state fMRI in iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients functional MRI were analzed. | Change from Baseline at 6 months after VP shunt |
| omic pattern of CSF in iNPH patients | Comparing the omic pattern differences in CSF between iNPH patients and normal age-matched normal volunteers by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed. | Before surgery in lumbar CSF |
| omic pattern of CSF in iNPH patients | Comparing the omic pattern differences in CSF of iNPH patients before surgery and after VP shunt by the analysis of mass spectrometry. Also, the responsive and non-responsive iNPH patients omic pattern were analzed. | Change from Baseline at 6 months after VP shunt |
| 38014747 | Background | Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28. |