UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036290 |
|---|---|
| Receipt number | 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 | 2023/09/27 12:04:36 |
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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
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
t_kashibayahshi@kochi-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry
Kochi Medical School, Kochi University,
Institute
Department
Personal name
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
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 08 | Day |
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
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041064
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
