Study of direct current stimulation in patients with refractory epilepsy

JRCT ID: jRCTs042190046

Registered date:21/06/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Refractory epilepsy
• Date of first enrollment: 01/07/2019
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Investigators has the tDCS research in the patients with refractory focal epilepsy and follows up for 1 month.

Outcome(s)

• Primary Outcome: Frequency of epilepsy

Secondary Outcome

1) EEG
2) SPECT
3) MRI

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Continued seizures despite adequate dosage in trials of at least 2 or more antiepileptic medications within approximately the last 3 years.
2) An established diagnosis of medically-refractory neocortical epilepsy (as determined by the referring clinician), with a clearly defined seizure focus. Diagnosis of epilepsy with focal seizures with or without secondary generalization (International League Against Epilepsy classification). Diagnosis established by clinical history and an electroencephalogram consistent with localization-related epilepsy.
3) 6 years old or older , 80 years old or younger
4) Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclude criteria

1) Any cranial metal implants (excluding dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator).
2) Previous surgeries opening the skull.
3) Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 4) History of non-epileptic or psychogenic seizures, Primary generalized seizures, Suspicion for or a significant history of syncope, Coexisting significant medical condition that is not in good control, Progressive neurologic disease, Progressive brain disorders, Serious systemic diseases, Symptomatic cerebrovascular disease, Cardiac disease, Chronic skin disease or Damaged skin on scalp that would interfere with tDCS stimulation.
5) Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
6) Any condition that makes the subject, in the opinion of the investigator, unsuitable for the study

Related Information

• Primary Sponsor: Kuroda Satoshi