Exploratory resarch on improvement of cognitive function by rTMS

JRCT ID: jRCTs052180034

Registered date:29/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy volunteer
• Date of first enrollment: 15/02/2018
• Target sample size: 80
• Study type: Interventional

Intervention(s)

Navigation-guided rTMS
site: temporo-parietal junction, dorsolateral prefrontal cortex, vertex etc.
stimulation method: Low-fequency stimulation(1Hz), High-frequency stimulation(10Hz), Theta burst stimulation, and Sham stimulation
intensity:
Low or High-frequency stimulation: less than 120% resting motor threshold(RMT)
Theta burst stimulation: less than 80% active motor threshold(AMT)
Sham stimulation: 0
number of pulses: less than 3000 pulses/session
number of sessions: 1 sessions

Outcome(s)

• Primary Outcome: Wisconsin Card Sorting Test (WCST), Trail Making Test (TMT)
• Secondary Outcome: Word Fluency test, Color Stroop Test (CST) etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Capability of informed consent
2) Aged 20-75 years-old

Exclude criteria

1) Implanted cardiac pacemaker
2) Surgical aneurysm clips
3) Neurostimulator
4) Implanted pumps
5) Metal fragments in body
6) Tattoos, permanent eyeliner (if ink contains metallic specks)
7) Diagnosis of neurological disorders (including epilepsy), substance dependence, or current serious medical illness (e.g. severe cardiac disease)
8) History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
9) Subjects with pregnancy or during lactation
10) Subjects who are judged as unsuitable for participation in this study

Related Information

• Primary Sponsor: Murai Toshiya
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology, Japan Agency for Medical Research and Development
• Secondary ID(s): UMIN000025720