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NCT Number: NCT06428734

Clinical Outcome in Patients With INPH

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.

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Key information

Conditions

Hydrocephalus Brain Diseases CSF Central Nervous System Diseases Glympathic System Idiopathic Normal Pressure Hydrocephalus Nervous System Diseases Omic

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fengzeng Jian

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Jian Fengzeng

CONTACT

[email protected]

Yuan Chenghua

CONTACT

[email protected]

xin qu, dr

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydrocephalus group

Diagnostic Test

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

normal group

Other

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

Primary outcomes

  1. DTIALPS

    Time frame: Change from Baseline at 6 months after VP shunt

    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.

Secondary outcomes

  1. Kiefer score

    Time frame: Change from Baseline at 6 months after VP shunt

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

  2. Mini mental state Examination

    Time frame: Change from Baseline at 6 months after VP shunt

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

  3. Gait evaluation

    Time frame: Change from Baseline at 6 months after VP shunt

    10 meters walking test were evaluated of iNPH patients.

  4. modified Rankin scale

    Time frame: Change from Baseline at 6 months after VP shunt

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

  5. Change in the resting state fMRI

    Time frame: Change from Baseline at 6 months after VP shunt

    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.

  6. omic pattern of CSF in iNPH patients

    Time frame: Before surgery in lumbar CSF

    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.

  7. omic pattern of CSF in iNPH patients

    Time frame: Change from Baseline at 6 months after VP shunt

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

fengzeng jian, md

CONTACT

[email protected]

01083198899

xin qu, md

CONTACT

[email protected]

01083198899

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Phenotypes, Biomarkers and Pathophysiology in INPH

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 24, 2024
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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