Verification of the safety and efficacy of Repetitive Transcranial Magnetic Stimulation for intractable epilepsy

JRCT ID: jRCTs032210051

Registered date:01/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: refractory epilepsy
• Date of first enrollment: 15/06/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): rTMS is delivered by a MagPro R30 (Inter Reha Co.,Ltd., Tokyo, Japan) at 0.9 Hz with a stimulus intensity of 90% of resting motor threshold (RMT), basically two sets of 15 min stimulation per day for 10 days in two weeks.

Outcome(s)

Primary Outcome

Occurrence of adverse events including predefined special interrest as shown below,
1)Novel patterns of paroxysmal abnormal electroencephalographic activity identified after manipulation
2)Hearing disturbance
3)Syncope
4)Focal pain at the place of magnetic stimuli
5)Mental deterioration
6)Functional disorders of the autonomic nerve system
7)New neurological symptoms and signs

Secondary Outcome

To verify the efficacy of rTMS defined as shown below,
1)Decrease of seizure frequency
2)Improvement of higher brain functions
3)Decrease of abnormal discharges in electroencephalogram

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1)Patients whose epileptic foci are identified by clinical or electroencephalographic data
2)Patients with uncontrollable seizures despite adequate medical therapy
3)Age at inclusion between 20 and 65
4)Regardless of patients sex
5)Patients who consent to join the present study with full understanding of the required and provided explanation
6)Patients who can visit or be admitted to the hospital according to the established schedule

Exclude criteria

1)Patients with a severe heart disorder
2)Patients with head skin or scalp problems due to infection or radiotherapy
3)Patients with a mental disorder
4)Patients with diagnosed or suspected pregnancy
5)Patients identified as inadequate for the present study by the principal investigator
6)Patients with unstable health conditions that required emergency treatment prior to that for epilepsy

Related Information

• Primary Sponsor: Kaito Nobuyoshi
• Source(s) of Monetary Support: Inter reha Co., Ltd.