Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)

NCT ID: NCT04998175

Last Updated: 2021-08-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Preoperative T1-MRI, functional MRI and diffusion MRI imaging data of iNPH patients were collected. The clinical assessment was performed before/after the lumbar puncture test and 6 months after VP shunt. Clinical assessment included Mini-mental State Examination (MMSE), gait scores, Kiefer score, and Modified Rankin Scale (mRS). The cerebrospinal fluid was collected by tap-test, and 6 months after surgery by puncturing in the VP device pump.

Methods- The primary methods used are:

1. The cerebrospinal fluid proteomic analysis of iNPH patients before and after VP shunt surgery.
2. The structral and functional MRI analysis of iNPH patients
3. The clinical assessment of MMSE, gait scores, Kiefer score, and mRS. Objective- To study the prognostic factors of VP shunt for iNPH.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Normal Pressure Hydrocephalus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

iNPH cohort

The patients diagnosed of iNPH.

Group Type EXPERIMENTAL

ventriculo-peritoneal shunt

Intervention Type PROCEDURE

A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ventriculo-peritoneal shunt

A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age ≥ 60 years;
* Diagnosis of iNPH based on clinical assessment
* Participant is able to give written informed consent

Exclusion Criteria

* Combining AD and Parkinson's disease and other nervous system diseases
* Participant is not medically available for shunt surgery
* Secondary NPH
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Westlake University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhoule Zhu

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The second affliated hospital of zhejiang university

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Junming Zhu, M.D.

Role: CONTACT

86-13968055768

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Junming Zhu, M.D

Role: primary

86-13968055768

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-796

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The CSF Shunt Entry Site Trial
NCT02425761 UNKNOWN PHASE3