Recruiting

Transcranial Direct Current Stimulation

Sponsor:

Mayo Clinic

Code:

NCT05673915

Conditions

Focal Epilepsy

Generalized Onset Epilepsy

Sleep-related Epileptic Encephalopathy

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)

ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)

Study Details

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

Study ID

NCT05673915

Start date

Apr 12, 2023

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Primary outcome measure

  • Seizure Count [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Precylla Ruiz

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

Izzie Meunier

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

Locations

Mayo Clinic Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Mayo Clinic

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-01-28.