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Device
Brain Stimulation for Epilepsy
N/A
Recruiting
Led By Brian Lundstrom, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
No Placebo-Only Group
Summary
This trial looks at how brain stimulation can reduce epileptic seizures.
Who is the study for?
This trial is for individuals with focal epilepsy who experience at least two seizures per month and haven't found seizure control with at least two anti-seizure medications. Participants must be able to maintain their current medication regimen, understand consent in English, and keep a seizure diary.
What is being tested?
The study tests whether electrical stimulation applied to the scalp using ActivaDose II device can reduce the frequency and intensity of epileptic seizures. There are two levels of stimulation being tested: low (0.1 mA) and standard (2.0 mA).
What are the potential side effects?
Potential side effects may include discomfort or skin irritation where the electrodes are placed on the scalp, headache, fatigue, nausea, or tingling sensations during or after treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Seizure Count
Secondary study objectives
EEG interictal discharge frequency
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: tDCS Treatment B (High Amplitude)Experimental Treatment1 Intervention
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The last treatment stimulation will be completed during the following 2-months.
Group II: tDCS Treatment A (Low Amplitude)Experimental Treatment1 Intervention
Subjects with focal epilepsy that is not well-controlled on anti-seizure medications will receive 2 different treatments periods, each lasting 2 months, of transcranial direct current stimulation (tDCS). The initial treatment stimulation will be completed during the first 2-months.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,333 Previous Clinical Trials
3,060,145 Total Patients Enrolled
22 Trials studying Epilepsy
1,051 Patients Enrolled for Epilepsy
Brian Lundstrom, MD, PhDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have at least two seizures every month that can be counted.You have not been able to manage seizures with at least two different seizure medications.Your illness is expected to get worse during the study.You have seizures that are not caused by epilepsy.You have tried to harm yourself or been in a psychiatric hospital in the past 2 years.You have a skin condition on your head that will get in the way of using scalp electrodes, or you are allergic to silver.Women will need to confirm they are not pregnant, and if needed, take a pregnancy test.You have been diagnosed with focal epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: tDCS Treatment B (High Amplitude)
- Group 2: tDCS Treatment A (Low Amplitude)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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