Clinical Outcome in Patients With INPH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-15

Study Completion Date

2027-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hydrocephalus Idiopathic Normal Pressure Hydrocephalus CSF Glympathic System Omic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hydrocephalus

high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

hydrocephalus group

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: 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

normal group

Intervention Type OTHER

Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

Interventions

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hydrocephalus group

Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

Intervention Type DIAGNOSTIC_TEST

normal group

Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes