Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05673915

Study of Transcranial Direct Current Stimulation to Treat Epilepsy

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)

Device

Stimulation setting 0.1 mA daily for a 2-month period. Each daily treatment will last for approximately 30 minutes.

ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)

Device

Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.

Primary outcomes

  1. Seizure Count

    Time frame: 2 months

    Number of seizures experienced by subjects as determined by self-reported seizure diary

Secondary outcomes

  1. EEG interictal discharge frequency

    Time frame: 2 months

    Number of interictal epileptiform discharges observed on electroencephalogram (EEG)

Study contacts

Contact information is provided by the study sponsor or research team.

Izzie Meunier

CONTACT

[email protected]

507-538-6337

Precylla Ruiz

CONTACT

[email protected]

507-538-6606

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2023
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.