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

JRCT ID: jRCT1052220196

Registered date:17/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Central Nervous System Diseases
• Date of first enrollment: 17/03/2023
• Target sample size: 160
• Study type: Interventional

Intervention(s)

A crossover assignment of "non-invasive brain stimulation + rehabilitation training" and "no non-invasive brain stimulation (sham stimulation) + rehabilitation training" will be conducted on 40 patients in each disabling function of motor dysfunction, higher brain dysfunction, language impairment, and swallowing dysfunction in patients with neurological diseases.
Brain stimulation is performed by transcranial static magnetic field stimulation (tSMS). Stimulation duration is three 30-minute sessions per day, one of which is combined with clinical rehabilitation training.
A neodymium magnet (N40) is used for tSMS and is fixed to the head with headgear.

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

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 neuology or otorhinolaryngology, Kyoto University Hospital or Murata Hospital
2 Patients who have developed cerebrovascular disorders, neurodegenerative diseases, involuntary movement diseases, neuroinflammatory 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 Other patients who are deemed unsuitable for the safe conduct of this study, such as those who are unable to remain at rest.

Related Information

• Primary Sponsor: Koganemaru Satoko