Study of Transcranial Direct Current Stimulation to Treat Epilepsy

Not Applicable

Recruiting

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

• Registration Number: NCT05673915
• Lead Sponsor: Mayo Clinic

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-12-30
• Study First Submitted QC: 2022-12-30
• Study First Posted: 2023-01-06
• Study Start: 2023-04-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
tDCS Treatment A (Low Amplitude)	ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)	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.
tDCS Treatment B (High Amplitude)	ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)	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.

Primary Outcome Measures

Name	Time	Method
Seizure Count	2 months	Number of seizures experienced by subjects as determined by self-reported seizure diary

Secondary Outcome Measures

Name	Time	Method
EEG interictal discharge frequency	2 months	Number of interictal epileptiform discharges observed on electroencephalogram (EEG)

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States