Clinical Outcome in Patients With INPH
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXuanwu Hospital, Beijing
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
patients who was diagnosed as idiopathic normal pressure hydrocephalus
Disqualifiers
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
Trial population
patients who was diagnosed as idiopathic normal pressure hydrocephalus
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
hydrocephalus group
Diagnostic testDiagnostic Test: high throughput sequencing and electromyography Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
normal group
Other interventionWhole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics and imaging, such as DTIALPS
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: hydrocephalus1 intervention
Group B: Normal group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from Baseline at 6 months after VP shuntSecondary outcomes
1
Kiefer score
A score for iNPH severity; range 0-26; higher indicates higher severity.
Time frame
Change from Baseline at 6 months after VP shunt2
Mini mental state Examination
A score for cognitive ability; range 0-30; higher indicates higher severity.
Time frame
Change from Baseline at 6 months after VP shunt3
Gait evaluation
10 meters walking test were evaluated of iNPH patients.
Time frame
Change from Baseline at 6 months after VP shunt4
modified Rankin scale
A score for functional neurological status ; range 0-5; higher indicates higher severity.
Time frame
Change from Baseline at 6 months after VP shuntSponsors and contacts
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Source ClinicalTrials.gov