Hydrocephalus Clinical Trial
Official title:
Phenotypes, Biomarkers and Pathophysiology in INPH
NCT number | NCT06428734 |
Other study ID # | XWCOPINPH |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2024 |
Est. completion date | May 2027 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Fengzeng Jian | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
China,
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
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 |
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