Actively Recruiting

Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06428734

Phenotypes, Biomarkers and Pathophysiology in Idiopathic Normal Pressure Hydrocephalus

Led by Xuanwu Hospital, Beijing · Updated on 2024-05-24

200

Participants Needed

1

Research Sites

50 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying idiopathic normal pressure hydrocephalus (iNPH) and related disorders to understand their clinical characteristics and natural progression. This prospective single-center study aims to identify digital, imaging, and molecular biomarkers that can help with diagnosis and therapy development. It also explores the causes and molecular mechanisms of these conditions to better understand their effects and outcomes. Participants are divided into groups including those diagnosed with hydrocephalus and a normal group. The study involves advanced diagnostic tests such as high throughput sequencing, whole genome and exome sequencing, transcriptomics, proteomics, metabolomics, and imaging techniques like DTIALPS. These tests are conducted to gather comprehensive data on the disease and its biomarkers. During study visits, patients undergo standardized clinical examinations and complete clinical rating scales. Biosamples such as blood, urine, cerebrospinal fluid, and muscle biopsies may be collected optionally. Additional assessments like neurophysiological exams, patient-reported outcomes, and imaging are also performed. Researchers measure changes from baseline in DTIALPS imaging and various clinical scales six months after ventriculoperitoneal shunt surgery. The study includes monitoring cognitive function, gait, and molecular patterns, with participation lasting through these assessments and follow-ups.

CONDITIONS

Brief Title

Clinical Outcome in Patients With INPH

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with idiopathic normal pressure hydrocephalus
  • Age between 18 and 80 years
  • Willingness and ability to complete study follow-up visits
Not Eligible

You will not qualify if you...

  • Patients who have received surgical or interventional treatment previously
  • Pregnant patients
  • Patients unable to complete follow-up
  • Patients with other types of hydrocephalus
  • Patients with other nervous system diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 months

Participants undergo diagnostic tests including high throughput sequencing, electromyography, whole genome sequencing, transcriptomics, proteomics, metabolomics, and imaging such as DTIALPS to assess their condition.

Multiple visits during the 6 months before surgery

Long-term Monitoring

Duration - 6 months after surgery

Participants are monitored over time with clinical rating scales and optional biosample collections including blood, urine, cerebrospinal fluid, and muscle biopsy. Additional optional examinations such as neurophysiological tests and imaging may occur to track disease progression and outcomes.

Regular visits during the 6 months after surgery

Trial Site Locations

Total: 1 location

1

Fengzeng Jian

Beijing, Beijing Municipality, China, 100053

Actively Recruiting

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Research Team

F

fengzeng jian, md

X

xin qu, md

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging.

Charalampos Georgiopoulos, Anders Tisell, Rafael T Holmgren...

https://pubmed.ncbi.nlm.nih.gov/37724800

Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis.

Chenghua Yuan, Pingchuan Xia, Wanru Duan...

https://pubmed.ncbi.nlm.nih.gov/38014747