Hydrocephalus, Idiopathic Normal Pressure Hydrocephalus, CSF, Glympathic System, Omic
Conditions
Keywords
Hydrocephalus, Idiopathic Normal Pressure Hydrocephalus
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESThydrocephalus group
Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
OTHERnormal group
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
Sponsors
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* patients who was diagnosed as idiopathic normal pressure hydrocephalus
Exclusion criteria
* patient received surgical treatment or interventional treatment before patient is pregnant patient unable to complete follow-up patient with other types of hydrocephalus other nervous system diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DTIALPS | Change from Baseline at 6 months after VP shunt | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mini mental state Examination | Change from Baseline at 6 months after VP shunt | A score for cognitive ability; range 0-30; higher indicates higher severity. |
| Gait evaluation | Change from Baseline at 6 months after VP shunt | 10 meters walking test were evaluated of iNPH patients. |
| Kiefer score | Change from Baseline at 6 months after VP shunt | A score for iNPH severity; range 0-26; higher indicates higher severity. |
| Change in the resting state fMRI | Change from Baseline at 6 months after VP shunt | 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. |
| omic pattern of CSF in iNPH patients | Before surgery in lumbar CSF | 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. |
| modified Rankin scale | Change from Baseline at 6 months after VP shunt | A score for functional neurological status ; range 0-5; higher indicates higher severity. |
Countries
China
Contacts
Primary Contactfengzeng jian, md
Backup Contactxin qu, md
Outcome results
None listed