Study of brain activity changes by electrical stimulation on scalp and rehabilitation

JRCT ID: jRCTs052210211

Registered date:30/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Central Nervous System Diseases
• Date of first enrollment: 30/03/2022
• Target sample size: 400
• 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 and rehabilitation training" group and 20 patients in the "no noninvasive brain stimulation (sham stimulation) and rehabilitation training" group. Forty healthy subjects were similarly randomly divided into two groups for each function, 20 in the "non-invasive brain stimulation and rehabilitation training" group and 20 in the "no non-invasive brain stimulation (sham stimulation) and rehabilitation training" group.
Brain stimulation is performed by transcranial direct current stimulation (tDCS). The stimulation time is 30 minutes, and is performed using a method that has been previously reported to be safe. The stimulating electrode area is 1 square centimeter with a current intensity of 5 mA, and the current intensity is modulated. The modulation frequency is between 0.5 and 650 Hz, and is determined for each patient based on EEG and EMG during tasks for each disorder. If the subject feels anxious, for example, the stimulation is too strong, the above stimulation parameters should be adjusted accordingly. In combination with this non-invasive brain stimulation, we perform rehabilitation training that is carried out in clinical practice.
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 in patients. 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

Patients) 1 Patients who are 18years of ag e or older at the time of consent to participate in th e study and are undergoing medical treatment at th e outpatient department of neurology or inpatient d epartment of Kyoto Ohara Memorial Hospital, Kyoto Konoe Rehabilitation Hospital, Gosyo Minami Rehab ilitation Clinic, or Kyoto University Hospital.
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
Healthy volunteers) (i) 18 to 90 years old at the time of consent
(ii) Have no history of neurological or psychiatric disorders
(iii) After receiving a full explanation of the purpose of participation in this study, the subject must give his/her free and voluntary written consent based on full understanding, or if the subject is unable to give his/her written consent, a proxy must give his/her written consent.

Exclude criteria

Patients) 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 has metals in the body which cannot be confirmed to be non-magnetic
*In the case of deep brain stimulating electrodes, however, since it has been reported that transcranial direct current stimulation is safe and effective when deep brain stimulation is stopped even when the electrode is intracranial, participation is possible when the deep brain stimulating electrode is intracranial but the stimulation is turned off.
4 Those who are judged inappropriate as a participant by the "Transcranial Magnetic Stimulation Test / Pre-Checklist" and "MR Test Pre-Checklist".
5 Those who are with claustrophobia
6 Any other person who is judged by the principal investigator to be inappropriate as a research subject
Healthy volunteers) 1 If he/she has a metal (aneurysm clips, mechanical prosthetic valves, nerve stimulators, insulin pumps, intraocular metal, etc.) in his/her body that cannot be confirmed to be non-magnetic.
2 In case of non compliance with the "Transcranial Magnetic Stimulation Test / Pre-Checklist" and "MR Test Pre-Checklist".
3 If the subject has claustrophobia
4 Other cases in which the principal investigator determines that the subject is inappropriate as a research subject.

Related Information

• Primary Sponsor: Hanakawa Takashi