NCT06428734

Clinical Outcome in Patients With INPH

Phenotypes, Biomarkers and Pathophysiology in INPH

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hydrocephalus
• Idiopathic Normal Pressure Hydrocephalus
• CSF
• Glympathic System
• Omic

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	hydrocephalus group	Diagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
OTHER	normal group	Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-05-15
• Completion: 2027-05-01
• First posted: 2024-05-24
• Last updated: 2024-05-24

Locations

1 site across 1 country: China