Refractory epilepsy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of epilepsy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) EEG 2) SPECT 3) MRI | — |
Contacts
Toyama University Hospital