Study of Transcranial Direct Current Stimulation to Treat Epilepsy

Mayo Clinic

Status: Enrolling

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

Treatments: Device: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS); Device: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05673915

22-008944

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

tDCS Treatment A (Low Amplitude)

Experimental group

Description:

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.

Treatment:

Device: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)

tDCS Treatment B (High Amplitude)

Experimental group

Description:

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.

Treatment:

Device: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)