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

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Zhejiang University

Status

Unknown

Conditions

Idiopathic Normal Pressure Hydrocephalus

Treatments

Procedure: ventriculo-peritoneal shunt

Study type

Interventional

Funder types

Other

Identifiers

NCT04998175
2020-796

Details and patient eligibility

About

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

Full description

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.

Enrollment

40 estimated patients

Sex

All

Ages

60 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

iNPH cohort
Experimental group
Description:
The patients diagnosed of iNPH.
Treatment:
Procedure: ventriculo-peritoneal shunt

Trial contacts and locations

1

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Central trial contact

Junming Zhu, M.D.

Data sourced from clinicaltrials.gov

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