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

JRCT ID: jRCTs032220329

Registered date:12/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild cognitive impairment
• Date of first enrollment: 12/09/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: MOCA-J total score after the intervention, amount of change from baseline

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

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.

Exclude criteria

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.

Related Information

• Primary Sponsor: Takakura Tomokazu
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research,The Watanabe Foundation