UMIN ID: UMIN000055411
Registered date:04/09/2024
Efficacy of low-frequency therapy in patients with drug-resistant refractory epilepsy
Basic Information
Recruitment status | Pending |
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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 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | 6years-old |
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Age maximum | 60years-old |
Gender | Male and Female |
Include criteria | |
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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | AMED |
Secondary ID(s) |
Contact
public contact | |
Name | Yuichi Kojima |
Address | Hokkaido University Hospital Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido Japan 060-8648 |
Telephone | 0117161161 |
yu1.kojima@pop.med.hokudai.ac.jp | |
Affiliation | Hokkaido Univesity Hospital Respiratory |
scientific contact | |
Name | Kiyoshi Egawa |
Address | Hokkaido University Hospital Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido Japan |
Telephone | 0117161161 |
yu1.kojima@pop.med.hokudai.ac.jp | |
Affiliation | Hokkaido University Hospital pediatrics |