Clinical trial NCT06428734: Clinical Outcome in Patients With INPH
Official title: Phenotypes, Biomarkers and Pathophysiology in INPH
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus
Idiopathic Normal Pressure Hydrocephalus
CSF
Glympathic System
Omic
Keywords: Hydrocephalus
Idiopathic Normal Pressure Hydrocephalus
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who was diagnosed as idiopathic normal pressure hydrocephalus

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: DTIALPS
timeFrame: Change from Baseline at 6 months after VP shunt
Secondary outcomes:
measure: Kiefer score
timeFrame: Change from Baseline at 6 months after VP shunt
measure: Mini mental state Examination
timeFrame: Change from Baseline at 6 months after VP shunt
measure: Gait evaluation
timeFrame: Change from Baseline at 6 months after VP shunt
measure: modified Rankin scale
timeFrame: Change from Baseline at 6 months after VP shunt
measure: Change in the resting state fMRI
timeFrame: Change from Baseline at 6 months after VP shunt
measure: omic pattern of CSF in iNPH patients
timeFrame: Before surgery in lumbar CSF
measure: omic pattern of CSF in iNPH patients
timeFrame: Change from Baseline at 6 months after VP shunt
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fengzeng Jian
state: Beijing
Study officials:
References:
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.
citation: 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.
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.