Brain activity changes induced by magnetic stimulation on scalp and rehabilitation

JRCT ID: jRCT1052210202

Registered date:23/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Central Nervous System Diseases
• Date of first enrollment: 23/03/2022
• Target sample size: 160
• Study type: Interventional

Intervention(s)

Forty patients will be randomly divided into two groups in each disability function of neurological disease patients, and assigned 20 patients in the "noninvasive brain stimulation + rehabilitation training" group and 20 patients in the "no noninvasive brain stimulation (sham stimulation) + rehabilitation training" group.
The Brain stimulation will be performed by randomly assigning either high frequency rTMS or low frequency rTMS. All stimulation durations will be 30 minutes. For high-frequency rTMS, the stimulation frequency will be 50 Hz, the stimulation intensity will be 120% of the resting motor threshold, and the duration of stimulation will be 10 seconds, with a minimum of 10 seconds between stimulation trains. The stimulation frequency for low-frequency rTMS should be 1 Hz. Low-frequency rTMS includes paired stimulation of multiple sites. If the subject feels anxious, for example, if the stimulation feels too intense, adjust the above stimulation parameters accordingly. In addition to these non-invasive brain stimulations, rehabilitation training is performed.
If the patients are assigned to the sham stimulation group, real stimulation is performed with the same protocol as in the present study after the intervention is completed.
To prevent dropout, a preliminary test for tolerability should be performed prior to the intervention. Tolerability is confirmed by performing as usual for one day with the parameters used and repeating several times with a washout period if necessary.

Outcome(s)

• Primary Outcome: Activity changes in EEG (analysis of EEG amplitude, frequency analysis)

Secondary Outcome

Amplitude values in each frequency band of MEG
Changes in cerebral blood flow during the task and at rest by fMRI
Motor evoked potential by TMS
Evaluation of motor and cognitive functions
Evaluation of neuroplasticity-related factors (BDNF, myokines)
Physical activities
Nutrition quantity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1 Patients who are 18years of age or older at the time of consent to participate in the study and are undergoing medical treatment at the outpatient or inpatient department of Kyoto Ohara Memorial Hospital, Kyoto Konoe Rehabilitation Hospital, Gosyo Minami Rehabilitation Clinic, or Kyoto University Hospital neurology or otorhinolaryngology departments
2 Patients who have developed cerebrovascular disorders, neuromuscular degenerative diseases, involuntary movement diseases, neuromuscular inflammatory diseases , central neurological disorders, or traumatic central neurological disorders, and for whom the diagnosis has been established by neurological findings, imaging findings
3 6 days or more after the onset of symptoms, or 6 days or more after the recurrence of symptoms
4 Patients suffering from any of the following disorders due to neurological diseases: motor disorder, higher brain dysfunction, language disorder, and dysphagia.
5 Patients who have given a full explanation and have given written consen from the person or proxy if written consent from the person is difficult to obtain.

Exclude criteria

1 5 days or more before the onset of symptoms, or 5 days or more before the recurrence of symptoms
2 Patients who are difficult to communicate due to significant hearing impairment
3 Patients who have a cardiac pacemaker
4 Ptients who has metals in the body which cannot be confirmed to be non-magnetic
5 Those who are judged inappropriate as a participant by the "Transcranial Magnetic Stimulation Test / Pre-Checklist" and "MR Test Pre-Checklist".
6 Those who are with claustrophobia
7 Any other person who is judged by the principal investigator to be inappropriate as a research subject

Related Information

• Primary Sponsor: Koganemaru Satoko