NCT06428734

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2024May 2027

Study Start

First participant enrolled

May 15, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 20, 2024

Last Update Submit

May 20, 2024

Conditions

HydrocephalusIdiopathic Normal Pressure HydrocephalusCSFGlympathic SystemOmic

Keywords

HydrocephalusIdiopathic Normal Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (1)

  • DTIALPS

    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.

    Change from Baseline at 6 months after VP shunt

Secondary Outcomes (7)

  • Kiefer score

    Change from Baseline at 6 months after VP shunt

  • Mini mental state Examination

    Change from Baseline at 6 months after VP shunt

  • Gait evaluation

    Change from Baseline at 6 months after VP shunt

  • modified Rankin scale

    Change from Baseline at 6 months after VP shunt

  • Change in the resting state fMRI

    Change from Baseline at 6 months after VP shunt

  • +2 more secondary outcomes

Study Arms (2)

hydrocephalus

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

Diagnostic Test: hydrocephalus group

Normal group

Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics

Other: normal group

Interventions

hydrocephalus groupDIAGNOSTIC_TEST

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

hydrocephalus
normal groupOTHER

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

Normal group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients who was diagnosed as idiopathic normal pressure hydrocephalus

You may qualify if:

  • patients who was diagnosed as idiopathic normal pressure hydrocephalus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fengzeng Jian

Beijing, Beijing Municipality, 100053, China

RECRUITING

Related Publications (3)

  • 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: 37010581BACKGROUND

  • 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: 37724800BACKGROUND

  • 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: 38014747BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood, cerebral spinal fluid, saliva, urine, biopsy and autopsy

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

fengzeng jian, md

CONTACT

01083198899jianfengzeng@xwh.ccmu.edu.cn

xin qu, md

CONTACT

01083198899xinqu@xwhosp.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

May 15, 2024

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

May 24, 2024

Record last verified: 2024-05

Locations

CN(1)