Study of Transcranial Direct Current Stimulation to Treat Epilepsy

Pilot Study of Transcranial Direct Current Stimulation (tDCS) 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.

Study Overview

• Status: Recruiting
• Conditions: Focal Epilepsy; Generalized Onset Epilepsy; Sleep-related Epileptic Encephalopathy
• Intervention / Treatment: Device: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS); Device: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Izzie Meunier; Phone Number: 507-538-6337; Email: meunier.isabelle@mayo.edu
• Study Contact Backup: Name: Precylla Ruiz; Phone Number: 507-538-6606; Email: ruiz.precylla@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS Treatment A (Low Amplitude); 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.	Device: ActivaDose 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.
Experimental: tDCS Treatment B (High Amplitude); 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.	Device: ActivaDose 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Count	Number of seizures experienced by subjects as determined by self-reported seizure diary	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG interictal discharge frequency	Number of interictal epileptiform discharges observed on electroencephalogram (EEG)	2 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Brian Lundstrom, MD, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: 22-008944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No