## Protocol Section
### Identification Module
**NCT ID:** NCT06428734

**Brief Title:** Clinical Outcome in Patients With INPH

**Official Title:** Phenotypes, Biomarkers and Pathophysiology in INPH

#### Organization Study ID Info
**ID:** XWCOPINPH
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2027-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-05-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xuanwu Hospital, Beijing

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hydrocephalus

- Idiopathic Normal Pressure Hydrocephalus

- CSF

- Glympathic System

- Omic

**Keywords:**

- Hydrocephalus

- Idiopathic Normal Pressure Hydrocephalus

### Design Module

#### Bio Spec

**Description:** Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 2 Years

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Diagnostic Test: hydrocephalus group

**Label:** hydrocephalus

#### Arm Group 2

**Description:** Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics

**Intervention Names:**

- Other: normal group

**Label:** Normal group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- hydrocephalus

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

**Name:** hydrocephalus group

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Normal group

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

**Name:** normal group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** DTIALPS

**Time Frame:** Change from Baseline at 6 months after VP shunt

#### Secondary Outcomes

**Description:** A score for iNPH severity; range 0-26; higher indicates higher severity.

**Measure:** Kiefer score

**Time Frame:** Change from Baseline at 6 months after VP shunt

**Description:** A score for cognitive ability; range 0-30; higher indicates higher severity.

**Measure:** Mini mental state Examination

**Time Frame:** Change from Baseline at 6 months after VP shunt

**Description:** 10 meters walking test were evaluated of iNPH patients.

**Measure:** Gait evaluation

**Time Frame:** Change from Baseline at 6 months after VP shunt

**Description:** A score for functional neurological status ; range 0-5; higher indicates higher severity.

**Measure:** modified Rankin scale

**Time Frame:** Change from Baseline at 6 months after VP shunt

**Description:** 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.

**Measure:** Change in the resting state fMRI

**Time Frame:** Change from Baseline at 6 months after VP shunt

**Description:** 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.

**Measure:** omic pattern of CSF in iNPH patients

**Time Frame:** Before surgery in lumbar CSF

**Description:** 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.

**Measure:** omic pattern of CSF in iNPH patients

**Time Frame:** Change from Baseline at 6 months after VP shunt

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients who was diagnosed as idiopathic normal pressure hydrocephalus

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jianfengzeng@xwh.ccmu.edu.cn

**Name:** fengzeng jian, md

**Phone:** 01083198899

**Role:** CONTACT

**Contact 2:**

**Email:** xinqu@xwhosp.org

**Name:** xin qu, md

**Phone:** 01083198899

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** yuanchenghua@ccmu.edu.cn

- **Name:** Yuan Chenghua

- **Role:** CONTACT

***Contact 2:***

- **Email:** jianfengzeng@xwh.ccmu.edu.cn

- **Name:** Jian Fengzeng

- **Role:** CONTACT

***Contact 3:***

- **Name:** xin qu, dr

- **Role:** SUB_INVESTIGATOR

**Country:** China

**Facility:** Fengzeng Jian

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100053

### References Module

#### References

**Citation:** Zhang C, Xu K, Zhang H, Sha J, Yang H, Zhao H, Chen N, Li K. Recovery of glymphatic system function in patients with temporal lobe epilepsy after surgery. Eur Radiol. 2023 Sep;33(9):6116-6123. doi: 10.1007/s00330-023-09588-y. Epub 2023 Apr 3.

**PMID:** 37010581

**Citation:** Georgiopoulos C, Tisell A, Holmgren RT, Eleftheriou A, Rydja J, Lundin F, Tobieson L. Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging. J Neurosurg. 2023 Sep 8;140(3):612-620. doi: 10.3171/2023.6.JNS23260. Print 2024 Mar 1.

**PMID:** 37724800

**Citation:** Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28.

**PMID:** 38014747

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M9907

- Name: Hydrocephalus

- Relevance: HIGH

- As Found: Hydrocephalus

- ID: M9908

- Name: Hydrocephalus, Normal Pressure

- Relevance: HIGH

- As Found: Normal Pressure Hydrocephalus

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006849

- Term: Hydrocephalus

- ID: D000006850

- Term: Hydrocephalus, Normal Pressure

### Misc Info Module

- Version Holder: 2024-05-31
