Clinical Outcome in Patients With INPH

Recruiting

• Conditions: Idiopathic Normal Pressure Hydrocephalus; Glympathic System; Hydrocephalus; Omic; CSF
• Interventions: Other: normal group; Diagnostic Test: hydrocephalus group

• Registration Number: NCT06428734
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-15
• Study First Submitted: 2024-05-20
• Study First Submitted QC: 2024-05-20
• Last Update Submitted: 2024-05-20
• Study First Posted: 2024-05-24
• Last Update Posted: 2024-05-24
• Primary Completion: 2026-05-15
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal group	normal group	Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
hydrocephalus	hydrocephalus group	high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Kiefer score	Change from Baseline at 6 months after VP shunt	A score for iNPH severity; range 0-26; higher indicates higher severity.
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.
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	Change from Baseline at 6 months after VP shunt	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.
Gait evaluation	Change from Baseline at 6 months after VP shunt	10 meters walking test were evaluated of iNPH patients.

Trial Locations

Locations (1)

Fengzeng Jian; 🇨🇳 Beijing, Beijing, China