UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036290
Receipt No. R000041064
Scientific Title Comprehensive study to improve long-term prognosis of patients with idiopathic normal pressure hydrocephalus
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comprehensive study to improve long-term prognosis of patients with idiopathic normal pressure hydrocephalus
Acronym Study to improve long-term prognosis of iNPH patients
Scientific Title Comprehensive study to improve long-term prognosis of patients with idiopathic normal pressure hydrocephalus
Scientific Title:Acronym Study to improve long-term prognosis of iNPH patients
Region
Japan

Condition
Condition idiopathic normal pressure hydrocephalus
healthy adult volunteer
Classification by specialty
Neurology Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 clarification of the long-term prognosis of iNPH patients and factors associated with the prognosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes modified Rankin scale(mRS)5 years after shunt surgery
Key secondary outcomes iNPH grading scale
evaluations of gait, cognition, urination and others

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
60 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) the age of onset of iNPH is defined as 60 years or older
2) More than one of the clinical triad: gait disturbance, cognitive impairment, and urinary incontinence on the iNPH grading scale (iNPHGS)
3) both ventriculomegaly of
Evans' index>0.3 and tight high-convexity and medial subarachnoid spaces on MRI
4) Above-mentioned clinical symptoms cannot be completely explained by other neurological or non-neurological diseases
Key exclusion criteria 1) no reliable family
2) no informed consent from the patients and their family about CSF Tap test and shunt surgery
3) the age at registration was over 80
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Kazui
Organization Kochi Medical School, Kochi University,
Division name Department of Neuropsychiatry
Zip code 783-8505
Address Kohasu Oko-cho, Nankoku, Kochi, Japan
TEL 088-880-2359
Email kazui@kochi-u.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Kashibayashi
Organization Kochi Medical School, Kochi University,
Division name Department of Neuropsychiatry
Zip code 783-8505
Address Kohasu Oko-cho, Nankoku, Kochi, Japan
TEL 088-880-2359
Homepage URL
Email t_kashibayahshi@kochi-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry
Kochi Medical School, Kochi University,
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kochi Medical School, Kochi University,
Address Kohasu Oko-cho, Nankoku, Kochi
Tel 088-866-5811
Email kms-info@kochi-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluations of gait, cognition, urination, and other symptoms, neuroimaging studies, and assessments of biomarkers in cerebrospinal fluid were performed before and after shunt surgery in iNPH patients. The evaluations after shunt surgery are repeated for five years. We analyze the association between results of the evaluation before shunt surgery and the outcome 5 years after shunt surgery.

Management information
Registered date
2019 Year 03 Month 25 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.