Brain activity changes by magnetic stimulation on scalp

JRCT ID: jRCT1052210071

Registered date:03/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Parkinson's syndrome including Parkinson's disease, stroke, spinocerebellar degeneration
• Date of first enrollment: 03/12/2021
• Target sample size: 320
• Study type: Interventional

Intervention(s)

Repetitive paired TMS includes paired stimuli that stimulate the motor cortex (M1) twice (ipsilateral M1-M1), the M1 and the contralateral M1 (contralateral M1-M1), the cerebellum and the M1 (Cbl-M1) and the peripheral motor nerve and the M1 (MN-M1). The generated electromyographic (EMG) response is appropriately fed back to the subject so that a stable stimulus-induced evoked potential can be obtained without mixing the voluntary movement.
Following the previous reports, the total number of paired stimuli shall be 600 times, and the stimulation interval shall be 0.2 seconds before and after each pair stimulation (5Hz). The stimulus intensity shall be 1.2 times the resting motor threshold (the intensity of the resting motor threshold is defined as the minimum stimulus intensity that causes muscle contraction when TMS stimulation is applied to the M1). However, if the subject feels anxious, such as when he/she feels that the stimulus is strong, the above stimulus parameters are adjusted as appropriate.
To prevent dropout, a preliminary test of tolerability should be performed prior to 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: Motor evoked potential by TMS

Secondary Outcome

Amplitude values in each frequency band of EEG, values measurted by structural and functional 7T-MRI to investigate connectivity between brain regions
Eye movement measurement

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

Selection criteria
Adults who consent to participate in the study

Healthy subjects)
Those who have no history of psychiatric disorders and have sufficient understanding and consent.

Neurological disease patients)
Adult patients who consent to participate in the study and who are undergoing medical treatment at the outpatient department of neurology or inpatient department of Kyoto University Hospital. The target disease is Parkinson's syndrome including Parkinson's disease, stroke, or spinocerebellar degeneration. Adults with 20 years old and over (18 years old and over after April 1, 2022) are targeted, but no other age / gender criteria are set.

Exclude criteria

Exclusion criteria
Healthy subjects)
1 Those who do not give consent to participate in the study
2 Those who have a significant obstacle to communication
3 Those who are judged inappropriate as a participant by the "Transcranial Magnetic Stimulation Test / Pre-Checklist" and "MR Test Pre-Checklist".
4 Those who are with claustrophobia

Neurological disease patients)
1 Those who are in a extremely poor general condition (such as abnormal vital signs)
2 Those who do not give consent for the research subject
3 Those who are judged inappropriate as a participant by the "Transcranial Magnetic Stimulation Test / Pre-Checklist" and "MR Test Pre-Checklist".
4 Those who are with claustrophobia

Related Information

• Primary Sponsor: Koganemaru Satoko