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.
Study Type
OBSERVATIONAL
Enrollment
200
Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
Fengzeng Jian
Beijing, Beijing Municipality, China
RECRUITINGDTIALPS
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.
Time frame: Change from Baseline at 6 months after VP shunt
Kiefer score
A score for iNPH severity; range 0-26; higher indicates higher severity.
Time frame: 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.
Time frame: Change from Baseline at 6 months after VP shunt
Gait evaluation
10 meters walking test were evaluated of iNPH patients.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: Change from Baseline at 6 months after VP shunt