A study of neural mechanism of non-invasive brain stimulation combined rehabilitation training.

JRCT ID: jRCTs012200016

Registered date:21/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neurological diseases
• Date of first enrollment: 06/09/2021
• Target sample size: 320
• Study type: Interventional

Intervention(s)

We perform brain stimulation with high frequency rTMS or low frequency rTMS or tDCS. All stimulation time should be within 30 minutes. As for high frequency rTM, the upper limit of stimulation frequency is 50 Hz, the upper limit of the stimulation intensity is set to 100% of the resting exercise threshold, continuous stimulation time is limited to 10 seconds and there are at least 10 seconds between stimulation train. As for low frequency rTMS, the stimulation frequency is less than 1 Hz.
As for tDCS, the current intensity is 1-5 mA and the stimulation electrode area is 3.5-100 square centimeters according to the method reported previously.Rehabilitation training is combined with non-invasive brain stimulation.

Outcome(s)

• Primary Outcome: Comparison of activity changes in EEG between brain stimulation intervention and sham stimulation intervention (power spectrum analysis and coherence analysis)

Secondary Outcome

I. Brain activity by magnetoencephalography (power spectrum analysis, coherence analysis)
II. fMRI (changes in cerebral blood flow at the task and at rest)
III. Evoked potential by TMS (Analysis of electroencephalograms and electromyograms changed by TMS to the stimulation site and the related sites)
IV. Function evaluation
1.If the disabled function is movement, muscle strength and muscle activity are measured by EMG. Conventional functional evaluation test (STEF, peg board, etc.) and 3D motion analysis are performed.
2.For cognitive dysfunction, conventional cognition evaluation (WAIS-III, TMT-A, B, S-PA, etc.) is performed.
3.For dysphasia, dysphasia evaluation tests (WAB, SLTA, ASMD, etc.) are performed.
4.For swallowing disorders, conventional swallowing evaluation (MWST, Fujishima swallowing grade etc.), image evaluation (VF, VE), and pharyngeal and esophageal manometry are performed,
V. Evaluation of neuroplasticity-related factors (Measurement of myokine concentration by blood sampling)
VI. Physical activities
VII. Nutrition quantity
VIII. Eye movement measurement

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

Patients with neurological disorders
1. Nervous disease patients who have the following target diseases and whose diagnosis is established by neurological findings, image findings, etc.
target diseases:
Cerebrovascular disease (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage etc.)
Neurodegenerative diseases (Parkinson's disease ,
Spinocerebellar degeneration etc.)
Neuroinflammatory disease (Multiple sclerosis etc.)
2. Patients who are suffering from any disorder due to neurological disorder, movement disorder, higher brain dysfunction, speech disorder, swallowing disorder.
3. Patients who received sufficient explanation to participate in this study and obtained document consent by the person's free will with sufficient understanding
4. Patients with movement disorders, higher brain dysfunction, speech disorders, or dysphagia due to neurological disorders
5. Patients who have received sufficient explanation before participating in this study, and who have obtained sufficient understanding and consent to the document at their own free will. Or, if it is difficult for the patient to consent to the document, the patient with the document consent obtained by the substitute

Healthy people
1. Those who are 20-90 years old at the time of obtaining consent
2. Those who have no history of neuropsychiatric illness in their declaration.
3. Persons who have received sufficient explanation before participating in this study, and who have obtained sufficient understanding and consent to the document at their own free will.

Exclude criteria

Patients with neurological disorders
1. Within 5 days after onset or within 5 days after symptom recurrence
2. Those who have significant hearing impairment and cannot communicate
3. Those who have a cardiac pacemaker
4. Those who are holding a body-metal that cannot be confirmed to be a non-magnetic material (aneurysm clip, mechanical artificial valve, nerve stimulator, insulin pump, intraocular metal, etc.)
5. Those who are judged by the principal investigator to be inappropriate as research subjects

Healthy people
1. Those who have significant hearing impairment and cannot communicate
2. Those who have a cardiac pacemaker
3. Those who are holding a body-metal that cannot be confirmed to be non-magnetic (aneurysm clip, mechanical artificial valve, nerve stimulator, insulin pump, intraocular metal, etc.)
4. Those who are judged by the principal investigator to be inappropriate as research subjects

Related Information

• Primary Sponsor: Mukaino Masahiko