UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040050 |
|---|---|
| Receipt number | R000045655 |
| Scientific Title | Change in intracortical inhibition before and after tap test among patients with idiopathic normal-pressure hydrocephalus |
| Date of disclosure of the study information | 2020/04/06 |
| Last modified on | 2023/03/03 16:14:57 |
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Basic information
Public title
Change in intracortical inhibition before and after tap test among patients with idiopathic normal-pressure hydrocephalus
Acronym
Change in intracortical inhibition before and after tap test
Scientific Title
Change in intracortical inhibition before and after tap test among patients with idiopathic normal-pressure hydrocephalus
Scientific Title:Acronym
Change in intracortical inhibition before and after tap test
Region
| Japan |
Condition
Condition
idiopathic normal-pressure hydrocephalus
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the relation between change in intracortical inhibition measured by TMS before and after tap test, motor, cognition, CSF biomarkers and prognosis after shunt surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
short latency afferent inhibition before and after tap test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
neurophysiological study using transcranial magnetic stimulation, before and 2-4days after tap test
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Without history of seizure, or medically stable condition of seizure
Without musculoskeltal or cardiac complication which hamper gait and physical function
Key exclusion criteria
Severe cardio-pulmonary disease
Severe Hypertension
Fever
Recent pulmonary infarction,
Severe liver dysfunction
Severe renal dysfunction
Severe Orthopedics problems
Severe metabolic disease
Cardiac pacemaker
Clipping, metal in the body
Contraindication of transcranial magnetic stimulation
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Takakura |
Organization
Juntendo University, Juntendo Tokyo Koto Geriatric Medical Center
Division name
Rehabilitation Medicine
Zip code
136-0075
Address
3-3-20 Shinsuna, Koto-ku, Tokyo, Japan
TEL
03-5632-3111
t-takakura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Takakura |
Organization
Juntendo University, Juntendo Tokyo Koto Geriatric Medical Center
Division name
Rehabilitation Medicine
Zip code
136-0075
Address
3-3-20 Shinsuna, Koto-ku, Tokyo, Japan
TEL
03-5632-3111
Homepage URL
t-takakura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Juntendo Tokyo Koto Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University, Juntendo Tokyo Koto Geriatric Medical Center
Address
3-3-20 Shinsuna, Koto-ku, Tokyo, Japan
Tel
03-5632-3111
kubota_kei@juntendo.gmc.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
| 2020 | Year | 04 | Month | 06 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045655
| 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 |
