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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027013
Receipt No. 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 2018/04/19

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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
Email 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
Email mano@neuromod.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 11 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
2017 Year 04 Month 17 Day
Last modified on
2018 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030967

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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