UMIN-CTR Clinical Trial

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
Email	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
Email	mitra.752001@yahoo.com

Sponsor
Institute	University of Science and Art
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053569