Brain activity changes induced by ultrasound stimulation on scalp and rehabilitation

JRCT ID: jRCTs052240221

Registered date:20/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Central Nervous System Diseases
• Date of first enrollment: 20/12/2024
• Target sample size: 400
• 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 and on 40 patients in each disabling function of motor dysfunction, higher brain dysfunction, language impairment, and swallowing dysfunction in patients with neurological diseases and will be conducted on 40 healthy controls in each function of motor function, higher brain function, language function, and swallowing function targeted by the intervention.
Brain stimulation is performed by transcranial ultrasound stimulation (TUS). Stimulation duration is 20-minute per day, combined with clinical rehabilitation training.
Neuro FUS Pro is used for TUS.

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 and brain structure during the task and at rest by fMRI
Motor evoked potentials 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 18 years of age or older at the time of consent to participate in the study and are undergoing medical treatment at the outpatient or inpatient in 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: Hanakawa Takashi