Study of Transcranial Direct Current Stimulation to Treat Epilepsy

NCT05673915 | Recruiting FDA Device

• 1 other identifier: 22-008944
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Seizure Count

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

  2 months

Secondary Outcomes (1)

• EEG interictal discharge frequency

  2 months

Study Arms (2)

tDCS Treatment A (Low Amplitude)

EXPERIMENTAL

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)

tDCS Treatment B (High Amplitude)

EXPERIMENTAL

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)

Interventions

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.

tDCS Treatment A (Low Amplitude)

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.

tDCS Treatment B (High Amplitude)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Brian Lundstrom, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Precylla Ruiz

CONTACT

507-538-6606; ruiz.precylla@mayo.edu

Izzie Meunier

CONTACT

507-538-6337; meunier.isabelle@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: April 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)