Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Inclusion Criteria:

1. 9 years old or older.

2. Diagnosis of epilepsy with focal seizures with or without focal to bilateraltonic-clonic seizures (International League Against Epilepsy classification).Diagnosis established by both clinical history and an EEG consistent with focalseizures. Note: A normal interictal EEG is consistent with focal seizures, if other data isadequate to provide localization.

3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizurecontrol despite demonstrated compliance, according to medical records, on at leasttwo (2) FDA-approved ASDs at a daily dose considered therapeutic for the patient'sdemographic according to package labeling, within approximately the last 3 years.

4. Seizure frequency average of ≥3 per month, over the past year.

5. Currently on at least 1 ASDs with no changes in antiepileptic drug doses in the 3weeks prior to baseline visit in the study and no planned dose changes during thetrial. Changes after baseline visit are permitted only if clinically necessary.

6. 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, aslong as the MRI was obtained after the onset of epilepsy and without brain surgeriesafter the MRI images.

7. Seizure focus that allows design of an appropriate stimulation montage. Note:Seizure focus can be identified within a lobe, or 2 adjacent lobes. Identificationof the border of the seizure focus can be approximate (+/- 2 gyri).

8. Available seizure history and supporting data

9. 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 aneffective method of birth control (defined as having a documented failure rate of <=1%; for women using enzyme-inducing ASDs hormonal contraceptives will not beconsidered as effective).

10. Written informed consent obtained from study patient or patient's legalrepresentative and ability for study patient to comply with the requirements of thestudy.

11. Assent from pediatric patients when appropriate.

Exclusion Criteria:

1. Presence of a condition or abnormality that in the opinion of the Investigator wouldcompromise the safety of the patient or the integrity of the data.

2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus isdefined as a cortical region confined to one hemisphere and either one lobe or on ajunction of two adjacent lobes from which seizures arise, as documented by scalp orintracranial EEG, that is either supported or not refuted by MRI, and eithersupported or not refuted by clinical semiology). If the interictal EEG is normal, aseizure focus may be identified by the combination of structural findings on MRI andclinical signs/symptoms associated with the patient's seizures.

3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal

4. Seizure focus is hemispheric or poorly defined

5. History of psychogenic non-epileptic seizures in past 2 years, or physiologicnonepileptic seizures and non-epileptogenic events, including suspicion for or asignificant history of syncope, and any non-epileptic events must be clearlydifferentiable from patient's focal seizures based on previously recorded video EEGshowing distinct clinical and electrographic features of the patient's psychogenicnon-epileptic seizures (PNES) compared to their epileptic seizures.

6. Seizures of generalized onset

7. Status epilepticus in the last 12 months

8. Presence of any disease, medical condition or physical condition that, in theopinion of the Investigator, may compromise interfere, limit, affect or reduce thepatient's ability to complete a study duration of 28 weeks (4 weeks screening, 12weeks baseline, 2 weeks tDCS, 10 weeks follow-up).

9. Presence of any disease, medical condition or physical condition that, in theopinion of the Investigator, may adversely impact the safety of the patient or theintegrity of the data.

10. Damaged skin on scalp that may interfere with tDCS stimulation.

11. Pregnant or unwilling to practice birth control during participation in the study.

12. Nursing mothers.

13. Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull platesand dental fillings) or medical devices (i.e., cardiac pacemaker, deep brainstimulator, medication infusion pump, cochlear implant). Note: Vagus nervestimulator (VNS) is allowable if the device is in MR Mode (e.g., switched off)during tDCS stimulation and the VNS device is MR conditional.

14. Previous surgeries opening the skull leaving skull defects capable of allowing theinsertion of a cylinder with a radius greater or equal to 5 mm.

15. Substance use disorder (including alcohol) according to Diagnostic and StatisticalManual, 5th edition (DSM-V) criteria in the past 3 years.

16. Participation in an interventional clinical trial within 30 days prior to screening.

17. Patient's head circumference > 64 cm