Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy

UMIN ID: UMIN000055411

Registered date:04/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: epilepsy
• Date of first enrollment: 2024/09/10
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Percentage reduction in the frequency of seizures per week during the observation period and duration of infrasound treatment compared to the previous observation period

Outcome(s)

• Primary Outcome: Percentage reduction in the frequency of seizures per week during the observation period and duration of infrasound treatment compared to the previous observation period

Key inclusion & exclusion criteria

• Age minimum: 6years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: Patients with any one of the following conditions shall be excluded (i) Patients with a history of progressive brain lesions (2) Patients receiving concomitant vagus nerve stimulation therapy (iii) Pregnant or lactating mothers (iv) Patients with skin hypersensitivity and a history of skin symptoms caused by metal or other substances (5) Patients who are abstinent or unable to use effective contraceptive methods during the period of participation in the study (vi) Patients who have difficulty in oral intake (vii) Patients with severe renal dysfunction (creatinine clearance less than 30 ml/min) (viii) Other subjects deemed inappropriate as research subjects by the principal investigator or subinvestigator.

Related Information

• Primary Sponsor: Hokkaido Univesity
• Source(s) of Monetary Support: AMED