Health TrialsbyHealthPanel

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

ConditionIdiopathic Normal Pressure Hydrocephalus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 60 years;

Diagnosis of iNPH based on clinical assessment

Participant is able to give written informed consent

Disqualifiers

Combining AD and Parkinson's disease and other nervous system diseases

Participant is not medically available for shunt surgery

Secondary NPH

Trial design

Design model

Single group

Treatments tested in this trial

  • ventriculo-peritoneal shunt

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: iNPH cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proteomic pattern of CSF in iNPH patients

Comparing the proteomic 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 proteomic pattern were analzed.

Time frame
Before surgery in lumbar CSF
2

Proteomic pattern changes of CSF in iNPH patients after VP shunt

Comparing the proteomic 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 proteomic pattern were analzed.

Time frame
Change from Baseline (ventricular CSF) at 6 months after VP shunt

Secondary outcomes

1

Gray Matter Density

Using automatic cortical and subcortical segmentation from the 3-dimensional T1weighted images to measure gray matter density in iNPH patients before surgery compared with healthy individual group. Also, the responsive and non-responsive iNPH patients structral MRI were analzed.

Time frame
Before surgery
2

Change in the resting state fMRI

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.

Time frame
Before surgery
3

White matter abnormity

Franctional anisotropy, mean diffusivity and apparent diffusion coefficient were measured by diffusion MRI in region of interest of iNPH patients compared with normal healthy group. Also, the responsive and non-responsive iNPH patients diffusion MRI were analzed.

Time frame
Beore surgery
4

Kiefer score

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

Time frame
Change from Baseline at 6 months after VP shunt

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Westlake University

Collaborator

Source ClinicalTrials.gov
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