Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02866240 : Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy
PhaseN/A
AgesMin: 9 Years Max: N/A
Eligibility
Inclusion Criteria:

- 9 years old or older

- 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.

- Continued seizures despite adequate dosage in trials of at least 2 or more
antiepileptic medications within approximately the last 3 years.

- At least one clearly identified and localizable epileptogenic zone from which 80% or
more seizures arise, as defined by the referring clinician.

- Currently on 1-4 anti-epileptic drugs (AEDs) 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 and through the primary endpoint

- A clinical or research MRI scan that is suitable for navigated brain stimulation (NBS)
and generation of electrical fields

- A reported average of at least 3 seizures per month (focal or secondarily generalized)
over the three months prior to enrollment, and a minimum of 4 seizures recorded during
the 8-week baseline period, with no 21-day seizure-free period during the 8 week
baseline

- Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative and ability for subject to comply with the requirements
of the study.

Exclusion Criteria:

- Pregnant, breastfeeding, or unwilling to practice birth control during participation
in the study. All female participants 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 including: oral hormonal contraceptives;
implanted hormonal contraceptives, diaphragm with spermicide; condoms; intra-uterine
device; abstinence.

- 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.

- Uncertainty regarding the diagnosis of medically-refractory epilepsy.

- History of Non-epileptic or psychogenic seizures, Primary generalized seizures, Status
epilepticus in the last 12 months, 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.

- 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).

- Previous surgeries opening the skull.

- Active or recent substance abuse or dependence within the past year.

- No medication is an absolute exclusion from tDCS/TMS. Medications will be reviewed and
a decision about inclusion will be made based on the following: patient's past medical
history, drug dose, history of recent medication changes or duration of treatment, and
combination with other central nervous system (CNS) active drugs. The published TMS
guidelines review of medications to be considered with TMS will be taken into
consideration.

- Any condition that makes the subject, in the opinion of the investigator, unsuitable
for the study
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02866240      |      Link to official Clinicaltrials.gov listing
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