Clinical Outcome in Patients With INPH

Hydrocephalus Clinical Trial

Official title:

Phenotypes, Biomarkers and Pathophysiology in INPH

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06428734
• Other study ID #: XWCOPINPH
• Status: Recruiting
• Start date: May 15, 2024
• Est. completion date: May 2027

Study information

• Verified date: May 2024
• Source: Xuanwu Hospital, Beijing
• Contact: fengzeng jian, md
• Phone: 01083198899
• Email: jianfengzeng[@]xwh.ccmu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2027
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• Idiopathic Normal Pressure Hydrocephalus

Intervention

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

Other:
• normal group
Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS

Locations

Country	Name	City	State
China	Fengzeng Jian	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (3)

Georgiopoulos C, Tisell A, Holmgren RT, Eleftheriou A, Rydja J, Lundin F, Tobieson L. Noninvasive assessment of glymphatic dysfunction in idiopathic normal pressure hydrocephalus with diffusion tensor imaging. J Neurosurg. 2023 Sep 8;140(3):612-620. doi: 10.3171/2023.6.JNS23260. Print 2024 Mar 1. — View Citation

Yuan C, Xia P, Duan W, Wang J, Guan J, Du Y, Zhang C, Liu Z, Wang K, Wang Z, Wang X, Wu H, Chen Z, Jian F. Long-Term Impairment of the Blood-Spinal Cord Barrier in Patients With Post-Traumatic Syringomyelia and its Effect on Prognosis. Spine (Phila Pa 1976). 2024 Mar 15;49(6):E62-E71. doi: 10.1097/BRS.0000000000004884. Epub 2023 Nov 28. — View Citation

Zhang C, Xu K, Zhang H, Sha J, Yang H, Zhao H, Chen N, Li K. Recovery of glymphatic system function in patients with temporal lobe epilepsy after surgery. Eur Radiol. 2023 Sep;33(9):6116-6123. doi: 10.1007/s00330-023-09588-y. Epub 2023 Apr 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DTIALPS	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.	Change from Baseline at 6 months after VP shunt
Secondary	Kiefer score	A score for iNPH severity; range 0-26; higher indicates higher severity.	Change from Baseline at 6 months after VP shunt
Secondary	Mini mental state Examination	A score for cognitive ability; range 0-30; higher indicates higher severity.	Change from Baseline at 6 months after VP shunt
Secondary	Gait evaluation	10 meters walking test were evaluated of iNPH patients.	Change from Baseline at 6 months after VP shunt
Secondary	modified Rankin scale	A score for functional neurological status ; range 0-5; higher indicates higher severity.	Change from Baseline at 6 months after VP shunt
Secondary	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.	Change from Baseline at 6 months after VP shunt
Secondary	omic pattern of CSF in iNPH patients	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.	Before surgery in lumbar CSF
Secondary	omic pattern of CSF in iNPH patients	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.	Change from Baseline at 6 months after VP shunt