Study of Transcranial Direct Current Stimulation to Treat Epilepsy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy

Conditions
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Focal Epilepsy

Intervention / Treatment
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* Device: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)
* Device: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Clinical diagnosis of focal epilepsy. Estimated to have at least 2 countable seizures per month. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS Treatment A (Low Amplitude)<br>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)<br>* Stimulation setting 0.1 mA daily for a 2-month period. Each daily treatment will last for approximately 30 minutes.<br>|
| Experimental: tDCS Treatment B (High Amplitude)<br>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)<br>* Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure Count | Number of seizures experienced by subjects as determined by self-reported seizure diary | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG interictal discharge frequency | Number of interictal epileptiform discharges observed on electroencephalogram (EEG) | 2 months |