UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046948 |
|---|---|
| Receipt number | R000053569 |
| Scientific Title | TMS on Alzheimer's Disease The effect of treatment of repetitive Transcranial Magnetic Stimulation on working memory of Alzheimer's Disease |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2022/02/19 04:13:13 |
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Basic information
Public title
The effect of treatment of repetitive Transcranial Magnetic Stimulation on working memory of Alzheimer's Disease
Acronym
The effect of T MS on working memory of Alzheimer's Disease
Scientific Title
TMS on Alzheimer's Disease
The effect of treatment of repetitive Transcranial Magnetic Stimulation on working memory of Alzheimer's Disease
Scientific Title:Acronym
The effect of T MS on working memory of Alzheimer's Disease
Region
| Asia(except Japan) |
Condition
Condition
Alzheimer's Disease
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Psychiatry |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of treatment of repetitive Transcranial Magnetic Stimulation on working memory of Alzheimer's Disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Phase I
Assessment
Primary outcomes
The effect tms of Alzheimer's Disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
In the first session, the patient's questionnaire was completed by his family and he signed the consent form. He was then given a 2-back test. He also experienced rTMS to relieve the patient's stress on the treatment protocol.
In the next session, the patient received rTMS for 10 consecutive days for 20 minutes, including high-frequency stimulation (10 Hz) on the left DLPFC area at a 45-degree angle of the coil with an intensity equal to 100% of the motor threshold. For the control group, changing the coil angle prevented the waves from reaching the brain.
Interventions/Control_2
In the first session, the patient's questionnaire was completed by his family and he signed the consent form. He was then given a 2-back test. He also experienced rTMS to relieve the patient's stress on the treatment protocol.
In the next session, the patient received rTMS for 10 consecutive days for 20 minutes, including high-frequency stimulation (10 Hz) on the left DLPFC area at a 45-degree angle of the coil with an intensity equal to 100% of the motor threshold. For the control group, changing the coil angle prevented the waves from reaching the brain.
Interventions/Control_3
In the first session, the patient's questionnaire was completed by his family and he signed the consent form. He was then given a 2-back test. He also experienced rTMS to relieve the patient's stress on the treatment protocol.
In the next session, the patient received rTMS for 10 consecutive days for 20 minutes, including high-frequency stimulation (10 Hz) on the left DLPFC area at a 45-degree angle of the coil with an intensity equal to 100% of the motor threshold. For the control group, changing the coil angle prevented the waves from reaching the brain.
Interventions/Control_4
In the first session, the patient's questionnaire was completed by his family and he signed the consent form. He was then given a 2-back test. He also experienced rTMS to relieve the patient's stress on the treatment protocol.
In the next session, the patient received rTMS for 10 consecutive days for 20 minutes, including high-frequency stimulation (10 Hz) on the left DLPFC area at a 45-degree angle of the coil with an intensity equal to 100% of the motor threshold. For the control group, changing the coil angle prevented the waves from reaching the brain.
Interventions/Control_5
In the first session, the patient's questionnaire was completed by his family and he signed the consent form. He was then given a 2-back test. He also experienced rTMS to relieve the patient's stress on the treatment protocol.
In the next session, the patient received rTMS for 10 consecutive days for 20 minutes, including high-frequency stimulation (10 Hz) on the left DLPFC area at a 45-degree angle of the coil with an intensity equal to 100% of the motor threshold. For the control group, changing the coil angle prevented the waves from reaching the brain.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 55 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A maximum of three years had not elapsed since the onset of the disease and the age range was 55 to 75 years and at least one year had elapsed since the onset of the disease.
Key exclusion criteria
There were other defects other than Alzheimer's, such as blindness and deafness, and the presence of epileptic seizures or seizures. The families of each person present in the study completed the consent form to participate in the research.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mohsen & zahra |
| Middle name | |
| Last name | saeidmanesh & babaei |
Organization
University of Science and Art
Division name
Faculty of Humanities
Zip code
0983538264080
Address
University of Science and Art, Daneshjoo Boulevard, Yazd
TEL
0983538264080
m.saeidmanesh@yahoo.com
Public contact
Name of contact person
| 1st name | zahra |
| Middle name | |
| Last name | babaei |
Organization
University of Science and Art
Division name
Faculty of Humanities
Zip code
0098 3538264080
Address
No 3. Opposite mobilization of Imam Sajjad. Imam Boulevard
TEL
0989139757808
Homepage URL
mitra.752001@yahoo.com
Sponsor or person
Institute
University of Science and Art
Institute
Department
Personal name
Funding Source
Organization
University of Science and Art
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Science and Art
Address
University of Science and Art, Daneshjoo Boulevard, Yazd
Tel
09139757808
mitra.752001@yahoo.com
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
| 2022 | Year | 12 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2022 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 01 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 19 | Day |
Last modified on
| 2022 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053569
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