Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
Pivotal-Safety and Therapeutic Measures of 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.
Study design is an evaluation of the STARSTIM device (tDCS) in subjects over 9 years of age,
 diagnosed with epilepsy with focal seizures with or without focal to bilateral tonic clonic
 seizures. Seizure diaries will be collected for 12 weeks to establish a rate of seizure for
 each subject prior to treatment. Subjects will be randomized in a 1:1 ratio to receive an
 active STARSTIM treatment or a sham treatment. Neither the study investigator nor subject
 shall be notified of the treatment assignment. Treatment will be done daily at the
 investigator's site for 10 days. A Seizure Diary will be maintained through the course of the
 treatment and the follow up period. Subjects will have 3 follow up visits to evaluate their
 seizure rate, adverse events, medications and quality of life. A Data Safety Monitoring Board
 will be utilized to evaluate safety events through study milestones. Seizure frequency rates
 pre, during and post treatment will be evaluated for both the active and sham treatment arms.
Inclusion Criteria:

 -  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 electroencephalogram (EEG) consistent with
 focal seizures.

 -  The subject has 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 ≥3 and ≤20 per month, over the past year.

 -  Currently on 1-4 ASDs with no changes in antiepileptic drug doses in the 3 weeks prior
 to enrollment in the study and no planned dose changes during the trial. Changes after
 enrollment are permitted only if clinically necessary.

 -  An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR
 sequences, performed within past 3 years and more recently than any craniotomy or
 skull burr hole procedure.

 -  Seizure focus that allows design of an appropriate stimulation montage (determined by
 sponsor review of seizure history)

 -  Available seizure history and supporting data for review by a sponsor committee

 -  All female study subjects of child-bearing 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 subject or subject's legal representative
 and ability for study subject to comply with the requirements of the study.

 -  Assent from pediatric subjects when appropriate.

 Exclusion Criteria:

 -  Presence of a condition or abnormality that in the opinion of the Investigator would
 compromise the safety of the subject or the integrity of the data.

 -  Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is
 defined as a neocortical region confined to one hemisphere and either one lobe or on a
 junction of two adjacent lobes from which seizures arise, as documented by scalp or
 intracranial EEG, that is either supported or not refuted by MRI, and either supported
 or not refuted by clinical semiology).

 -  Seizure focus is one of: interhemispheric, cingulate, mesiotemporal, or orbitofrontal

 -  Seizure focus is hemispheric or poorly defined

 -  History of psychogenic nonepileptic seizures, or physiologic nonepileptic seizures and
 Non-epileptogenic events, including suspicion for or a significant history of syncope

 -  Seizures of generalized onset

 -  Status epilepticus in the last 12 months

 -  Presence of any disease, medical condition or physical condition that, in the opinion
 of the Investigator, may compromise interfere, limit, effect or reduce the subject's
 ability to complete a study of 24 weeks duration.

 -  Presence of any disease, medical condition or physical condition that, in the opinion
 of the Investigator, may adversely impact the safety of the subject or the integrity
 of the data.

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

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

 -  Nursing mothers.

 -  Any cranial metal implants (excluding ≦1 mm thick epicranial titanium skull plates and
 dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator,
 medication infusion pump, cochlear implant, vagus nerve stimulator).

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

 -  A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use
 of any illicit substance.