Focal Epilepsy, Generalized Onset Epilepsy, Sleep-related Epileptic Encephalopathy
Conditions
Brief summary
The purpose of this research is to see to what extent electrical stimulation applied to the scalp (transcranial direct current stimulation or tDCS) can reduce the number and intensity of epileptic seizures.
Detailed description
tDCS for treatment of epilepsy has been studied previously with results suggesting that it can lead to a notable seizure reduction for a limited time period after the cessation of stimulation, e.g., about one month. Here, we assess further aspects of tDCS treatment protocols, including the feasibility and safety of at-home use.
Interventions
DEVICEActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)
Stimulation setting 0.1 mA daily for a 2-month period. Each daily treatment will last for approximately 30 minutes.
DEVICEActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of generalized onset or focal epilepsy or sleep-related epileptic encephalopathy. * Estimated to have at least 2 countable seizures per month or spike-wave index ≥50%. * Has not had control with at least 2 anti-seizure medicines. * Able to maintain a constant medication for duration of the study (rescue meds allowed). * Subject or legally authorized representative is able to understand consent and keep a seizure diary in English.
Exclusion criteria
* A disease likely to progress over course of the study. * Psychogenic non-epileptic seizures. * Suicide attempt or psychiatric hospitalization past 2 years. * A skin condition interfering with scalp electrodes or allergy to silver. * Women will verify not pregnant, and if applicable, have a serum pregnancy test. * Implanted devices (e.g. pacemakers)-except VNS, which is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Count | 2 months | Number of seizures experienced by subjects as determined by self-reported seizure diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG interictal discharge frequency | 2 months | Number of interictal epileptiform discharges observed on electroencephalogram (EEG) |
Countries
United States
Contacts
CONTACTPrecylla Ruiz
CONTACTIzzie Meunier
PRINCIPAL_INVESTIGATORBrian Lundstrom, MD, PhD
Mayo Clinic
Outcome results
None listed