Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy (NCT02866240) | Clinical Trial Compass
CompletedNot Applicable
Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy
United States20 participantsStarted 2017-09-21
Plain-language summary
This is a single site, non-randomized, prospective, open-label, interventional pilot/feasibility study. Patients recruited will have medically-refractory focal neocortical epilepsy, defined on the basis of presence of focal spikes and (if available) focal seizure onsets originating from the lateral cortical surface of any lobe. All patients and referring physicians will be requested to maintain their current antiepileptic drugs throughout the study with changes after enrollment permitted only to maintain pre-enrollment drug levels, or if clinically necessary. The primary outcome measure will be the change in seizure frequency (seizures/week) as compared to baseline.
Patients with medically-refractory neocortical epilepsy will receive cathodal tDCS administered to the seizure focus for 10 sessions over a 2-week period with the allowance of make-up sessions in week three. Subjects will be evaluated at baseline, during the stimulation sessions, and 8 weeks after the completion of the tDCS visits
Who can participate
Age range
9 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Seizure frequency in patients with intractable focal neocortical epilepsy using cathodal tDCS.