UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033026 |
|---|---|
| Receipt number | R000037651 |
| Scientific Title | Analysis of tap test responsiveness in neurodegenerative disorders |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2018/06/25 15:06:55 |
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Basic information
Public title
Analysis of tap test responsiveness in neurodegenerative disorders
Acronym
Analysis of tap test responsiveness in neurodegenerative disorders
Scientific Title
Analysis of tap test responsiveness in neurodegenerative disorders
Scientific Title:Acronym
Analysis of tap test responsiveness in neurodegenerative disorders
Region
| Japan |
Condition
Condition
Parkinson's disease, Lewy body disease, progressive supranuclear palsy, idiopathic normal pressure hydrocephalus
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to reveal whether tap test is effective for neurodegenerative disorders or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait velocity variability before and after tap test
Key secondary outcomes
Stride length and height of the legs variability before and after tap test
Cognitive function test variability before and after tap test
OABSS and IPSS before and after tap test
Functional connectivity variability on functional MRI study before and after tap test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Cerebrospinal fluid tap test+sham tap test
Interventions/Control_2
Cerebrospinal fluid tap test+sham tap test
Interventions/Control_3
Cerebrospinal fluid tap test+sham tap test
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a clinical diagnosis of iNPH, PSP, PD/DLB were enrolled.
Key exclusion criteria
1. patients with intracranial hypertension
2. patients who have infection at puncture site
3. patients with patients with hemorrhagic diathesis
4. patients who have antiplatelet drug or anticoagulant drug and are difficult to stop such a medication
5. patients with metallic implants
6. patients with claustrophobia
7. patients with unstable vital signs
8. patients who are under 40 years old or who can not express their intension
9. pregnant women
10. patients who are considered to be not suitable for the study
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Yokota |
Organization
Tokyo Medical and Dental University
Division name
Department of Neurology and Neurological Science
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-3813-6111
tak-yokota.nuro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takaaki Hattori |
Organization
Tokyo Medical and Dental University
Division name
Department of Neurology and Neurological Science
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo 113-8519, Japan
TEL
03-3813-6111
Homepage URL
takaaki-hattori@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University, Department of Neurology and Neurological Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University, Department of Neurology and Neurological Science
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
Address
Tel
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
| 2018 | Year | 07 | 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
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | 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
Management information
Registered date
| 2018 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037651
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
