UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027013 |
|---|---|
| Receipt number | R000030967 |
| Scientific Title | the non-invasive brain stimulation therapy for Alzheimer's disease |
| Date of disclosure of the study information | 2017/05/18 |
| Last modified on | 2020/04/27 19:04:56 |
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Basic information
Public title
the non-invasive brain stimulation therapy for Alzheimer's disease
Acronym
repetitive transcranial magnetic stimulation for Alzheimer's disease
Scientific Title
the non-invasive brain stimulation therapy for Alzheimer's disease
Scientific Title:Acronym
repetitive transcranial magnetic stimulation for Alzheimer's disease
Region
| Japan |
Condition
Condition
Alzheimer's Disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of rTMS in Alzheimer's Disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ADAS-cog
Key secondary outcomes
MMSE, NPI, SC-BADA, Stroop test, functional MRI(Brain connectivity in resting state),EEG(LORRETA analysis)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rTMS over the bil.DLPFC
10Hz 120%RMT 4sec stimulation
26sec inter train interval
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Alzheimer's dementia patient passed more than one year after the diagnosis
2. Patient with less than MMSE 25 points3. the cognitive function is insufficient
4. less than 20 years or older than 85 years old
5. The patient is provided in a document about the participation in this clinical study
Key exclusion criteria
1.Patient with severe cognitive function
2.Severe aphasia, agnosia and aprxia
3.serious mental disorder
4.suicidal tendencies
5.the past of the epilepsy attack
6.the shrubbery model heart stimulation and assistance devices such as pacemakers
7.deep brain stimulation device
8.shrubbery metal on the head (except the titanium product)
9.Pregnant
10.Patient cannot answer a questionnaire
11.Patients received intervention in other clinical trials or a clinical trial within six months before the agreement acquisition
12.Patients are inappropriate as an object enrolled of this study
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youichi Saitoh |
Organization
Department of Neuromodulation and Neurosurgery
Division name
Osaka University Graduate School of Medicine
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6210-8435
saitoh@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Mano |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neuromodulation and Neurosurgery
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6210-8435
Homepage URL
mano@neuromod.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
| 2017 | Year | 05 | Month | 18 | 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
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 17 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030967
| 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 |
