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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023063
Receipt No. 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 2018/07/10

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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
Middle name
Last name Nishida Namiko
Organization Tazuke Kofukai Medical Research Institute
Kitano Hospital
Division name Department of Neurosurgery
Zip code
Address 2-4-20, Ohgimachi, Kita-ku, Osaka City
TEL 06-6312-1221
Email n-nishida@kitano-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nishida Namiko
Organization Tazuke Kofukai Medical Research Institute Kitano Hospital
Division name Department of Neurosurgery
Zip code
Address 2-4-20, Ohgimachi, Kita-ku, Osaka City
TEL 06-6312-1221
Homepage URL
Email n-nishida@kitano-hp.or.jp

Sponsor
Institute Tazuke Kofukai Medical Research Institute
Kitano Hospital
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
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
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026583

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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