Study of Transcranial Direct Current Stimulation to Treat Epilepsy

NCT ID: NCT05673915

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2026-12-31

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.

Conditions

Focal Epilepsy; Generalized Onset Epilepsy; Sleep-related Epileptic Encephalopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Brian N. Lundstrom

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Lundstrom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Precylla Ruiz

Role: CONTACT

ruiz.precylla@mayo.edu

507-538-6606

Izzie Meunier

Role: CONTACT

meunier.isabelle@mayo.edu

507-538-6337

Other Identifiers

22-008944

Identifier Type: -

Identifier Source: org_study_id