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


About this study

The purpose of this study is to evaluate effectiveness, 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 addietional 10 weeks post treatment. Quality of Life questionnaires and adverse events will be collected and evaluated.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. 9 years old or older

2. 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. Note: A normal interictal EEG is consistent with focal seizures if
other data is adequate to provide localization.

3. 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.

4. Seizure frequency >= 3 per month over the past year.

5. Currently on at least 1 ASD, 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.

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

7. 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).

8. Available seizure history and supporting data

9. 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

10. 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.

11. Assent from pediatric subjects when appropriate.

Exclusion Criteria:

1. 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.

2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is
defined as a cortical 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). If the interictal EEG is normal, a seizure
focus may be identified by the combination of structural findings on MRI and clinical
signs/symptoms associated with the subject'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 physiologic
nonepileptic seizures and non-epileptogenic events, including suspicion for or a
significant history of syncope, and any non-epileptic events must be clearly
differentiable from subject's focal seizures based on previously recorded video EEG
showing distinct clinical and electrographic features of the subject's 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 the opinion
of the Investigator, may compromise interfere, limit, affect or reduce the subject's
ability to complete a study of 24 weeks duration.

9. 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.

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 plates and
dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator,
medication infusion pump, cochlear implant, vagus nerve stimulator).

14. 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.

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


Eligibility last updated 7/1/22]. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brian Lundstrom, M.D., Ph.D.

Open for enrollment

Contact information:

Bridget Neja C.N.A.

(507) 266-9150


More information


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