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Japanese

Sept. 12, 2022

Sept. 30, 2025

jRCTs032220329

The effect of short term intensive cognitive training using repetitive transcranial magnetic stimulation for mild cognitive impairment (The effect of intensive cognitive training using rTMS for MCI)

The effect of short term intensive cognitive training using repetitive transcranial magnetic stimulation for mild cognitive impairment (The effect of intensive cognitive training using rTMS for MCI)

Jan. 31, 2025

4

Number of registered patients: 4 (2 males, 2 females), average age: 73 (61-79), of whom 1 withdrew after enrollment but before the start of the study. We were able to conduct an intervention study on 3 participants (2 males, 1 female) with an average age of 71.6 (61-79).

Due to the global pandemic of the new coronavirus infection (COVID-19), which began in January 2020, there were constraints in conducting this research. During the planned registration period from September 12, 2022 to January 31, 2025, we set a target number of cases of 30 cases (15 cases in each group) and actively tried to recruit subjects through the hospital website, public relations, etc., but it was difficult to secure subjects. Consent was obtained from 4 subjects, of whom 1 withdrew before the start of the intervention, so the intervention study was conducted on 3 subjects.

No serious complications or illnesses were observed.

Due to the small number of registered cases, the results of this study were unable to confirm the cognitive function improvement effect or physiological changes due to the combination of rTMS and CACR.

Due to the small number of registered cases, the results of this study were unable to confirm the cognitive function improvement effect or physiological changes due to the combination of rTMS and CACR.

Sept. 30, 2025

No

No plans to share data

https://jrct.mhlw.go.jp/latest-detail/jRCTs032220329

Takakura Tomokazu

Juntendo Tokyo Koto Geriatric Medical Center

3-3-20 Shinsuna, Koto-ku, Tokyo

+81-3-5623-3111

t-takakura@juntendo.ac.jp

Takakura Tomokazu

Juntendo Tokyo Koto Geriatric Medical Center

3-3-20 Shinsuna, Koto-ku, Tokyo

+81-3-5632-3111

t-takakura@juntendo.ac.jp

Complete

Sept. 12, 2022

Nov. 07, 2022
30

Interventional

randomized controlled trial

single blind

placebo control

parallel assignment

treatment purpose

1. Be aware of forgetfulness.
2. Housework and activities of daily living are generally normal.
3. Age more than or equal to 60 years and less tha 80 years.
4. Those who can go to the hospital according to the test protocol.
5. Written informed consent to participate in this study.

1.Under treatment for epilepsy/depression/mania/ schizophrenia.
2.Who have a cardiac pacemaker, implantable defibrillator, metal near the stimulation site (cochlear implant, magnetic clip, deep brain stimulation / vagus nerve stimulation), or implantable drug solution pump.
3. Severe heart disease:unstable angina,short-term myocardial infarction from onset, decompensated congestive heart failure, acute pulmonary heart, uncontrolled arrhythmia, severe aortic stenosis, active Myocarditis, endocarditis, etc.
4. Uncontrolled hypertension
5. Acute systemic illness or fever
6. Complications of recent pulmonary embolism, acute cor pulmonale, and severe pulmonary hypertension
7. Complication of severe hepatic / renal dysfunction
8. Severe orthopedic complications
9. Severe cognitive impairment (MMSE-J less tha or equal to 20/30), complications of severe mental illness
10. Other metabolic disorders (such as acute thyroiditis)
11. When using drugs that lower the threshold of spasm attacks (tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine) and abuse of alcohol, caffeine, stimulants, etc.
12. Lactating women
13. Other patients who are judged by the research-responsible (sharing) doctor to be inappropriate as research subjects.

60age old over
80age old not

Both

Mild cognitive impairment

Cognitive rehabilitation of 3 times per week during 2weeks, using computer training software for 40 minutes after repetitive transcranial magnetic stimulation (theta burst or sham stimulation) for 3minutes 20 second.

forgetfullness, MCI

ognitive therapy, repetitive transcranial magnetic stimulation

D060825

D015928, D050781

MOCA-J total score after the intervention, amount of change from baseline

Scores after the intervention as below.
1.MOCAJ subitems (visual space-execution system, naming, attention, language, abstract concept, delayed reproduction, orientation)
2.Spatial working memory (PUME on RehaCom software)
3.Digit Span (number of forward spans)
4.Verbal working memory, Reading Span Test (span score)
5.Word Fluency Test (total number of recalls)
6.Electrophysiological evaluations, RMT, SAI (ISI grand mean from 21 to 25ms)

Grants-in-Aid for Scientific Research
The Watanabe Foundation
Juntendo Hospital Certified Review Board
2-1-1 Hongo, Bunkyo-ku, Tokyo, Tokyo

+81-3-5802-1584

crbjun@juntendo.ac.jp
Approval

Sept. 01, 2022

none

History of Changes

No Publication date
4 Sept. 30, 2025 (this page) Changes
3 June. 26, 2025 Detail Changes
2 June. 11, 2025 Detail Changes
1 Sept. 12, 2022 Detail