UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023063 |
|---|---|
| Receipt number | R000026583 |
| Scientific Title | Study on the uneven CSF distribution, cerebral white matter damage and L-PGDS in idiopathic normal pressure hydrocephalus |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2024/11/15 00:46:15 |
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Basic information
Public title
Study on the uneven CSF distribution,
cerebral white matter damage and L-PGDS
in idiopathic normal pressure hydrocephalus
Acronym
Study on the brain imaging and L-PGDS in iNPH
Scientific Title
Study on the uneven CSF distribution,
cerebral white matter damage and L-PGDS
in idiopathic normal pressure hydrocephalus
Scientific Title:Acronym
Study on the brain imaging and L-PGDS in iNPH
Region
| Japan |
Condition
Condition
Idiopathic normal pressure hydrocephalus
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the underlying mechanism
in idiopathic normal pressure hydrocephalus
Basic objectives2
Others
Basic objectives -Others
Confirm the relationship between CSF
biomarkers and MRI findings. Investigate
underlying mechanism.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Symptoms (iNPHGS/FAB/MMSE/TUG/MDS_UPDRS)
Key secondary outcomes
CSF markers (L-PGDS/Tau/Abeta)
MRI (ARWMC scores/FA/MD)
Sleep (PSQI/ESS/polysomnography)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with one of cardinal three symptoms (gait, bladder, cognition) and cerebral
ventriculomegaly.
Key exclusion criteria
Contraindication of lumber puncture.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Namiko |
| Middle name | |
| Last name | Nishida |
Organization
Tazuke Kofukai Medical Research Institute
Kitano Hospital
Division name
Department of Neurosurgery
Zip code
530-8480
Address
2-4-20, Ohgimachi, Kita-ku, Osaka City
TEL
06-6312-1221
n-nishida@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | Namiko |
| Middle name | |
| Last name | Nishida |
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name
Department of Neurosurgery
Zip code
530-8480
Address
2-4-20, Ohgimachi, Kita-ku, Osaka City
TEL
06-6312-1221
Homepage URL
n-nishida@kitano-hp.or.jp
Sponsor or person
Institute
Tazuke Kofukai Medical Research Institute
Kitano Hospital
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of
Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tazuke Kofukai Medical Research Institute Kitano Hospital
Address
2-4-20, Ohgimachi, Kita-ku, Osaka City
Tel
06-6312-1221
rinshou@kitano-hp.or.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
| 2016 | Year | 07 | Month | 11 | 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
Main results already published
Date of protocol fixation
| 2015 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
anterograde study (2016/1/1-2018/3/31)
retrograde study (2012/5/1-2015/12/28)
For the retrograde part, we check the waivers
of informed consent by posters or bulletin
boards.
anterograde study will extended to 2019/3/31
Management information
Registered date
| 2016 | Year | 07 | Month | 07 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026583
