STARSTIM: SAFETY AND THERAPEUTIC MEASURES OF TRANSCRANIAL CATHODAL DIRECT CURRENT STIMULATION (TDCS) IN PATIENTS WITH REFRACTORY FOCAL EPILEPSY
This is a multiple site, randomized, double blinded parallel-group controlled study. The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial cathodal direct current stimulation (tDCS). Subjects will be treated with STARTSTIM or sham device for 10 sessions over a 2-week period. The subjects will be followed for an additional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.
• 9 years old or older.
• Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic-clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures.
• Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.
• Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure control despite demonstrated compliance, according to medical records, on at least two (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's demographic according to package labeling, within approximately the last 3 years.
• Seizure frequency average of ≥3 per month, over the past year.
• Currently on at least 1 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior to baseline visit in the study and no planned dose changes during the trial. Changes after baseline visit are permitted only if clinically necessary.
• An MRI scan of the brain using a 1.5 Tesla magnet, or greater, with T1, T2 (recommended), and FLAIR sequences, acquired within the last 3 years for children (patients \<18 years old), or within 5 years for adult patients ≥18 years old, as long as the MRI was obtained after the onset of epilepsy and without brain surgeries after the MRI images.
• Seizure focus that allows design of an appropriate stimulation montage. Note: Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identification of the border of the seizure focus can be approximate (+/- 2 gyri).
• Available seizure history and supporting data
• All female study subjects of childbearing age are required to have a pregnancy test. Additionally, all females of childbearing potential will be required to use an effective method of birth control (defined as having a documented failure rate of \<=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as effective).
⁃ Written informed consent obtained from study patient or patient's legal representative and ability for study patient to comply with the requirements of the study.
⁃ Assent from pediatric patients when appropriate.