NCT05673915NARecruiting
Study of Transcranial Direct Current Stimulation to Treat Epilepsy
Mayo Clinic
Start Date
4/12/2023
Completion Date
12/1/2026
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.
Eligibility Criteria
Age Range: 6 years to No maximum
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.
Interventions
DEVICE
ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)
DEVICE
ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
Conditions
Focal EpilepsyGeneralized Onset EpilepsySleep-related Epileptic Encephalopathy
Locations
Mayo Clinic Minnesota
Rochester, Minnesota 55905
United States