Study of Transcranial Direct Current Stimulation to Treat Epilepsy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: 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.
|
| 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Seizure Count [2 months]
Number of seizures experienced by subjects as determined by self-reported seizure diary
Secondary Outcome Measures
- EEG interictal discharge frequency [2 months]
Number of interictal epileptiform discharges observed on electroencephalogram (EEG)
Eligibility Criteria
Criteria
Inclusion Criteria
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Clinical diagnosis of focal epilepsy.
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Estimated to have at least 2 countable seizures per month.
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Has not had control with at least 2 anti-seizure medicines.
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Able to maintain a constant medication for duration of the study (rescue meds allowed).
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Subject or legally authorized representative is able to understand consent and keep a seizure diary in English.
Exclusion Criteria:
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A disease likely to progress over course of the study.
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Psychogenic non-epileptic seizures.
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Suicide attempt or psychiatric hospitalization past 2 years.
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A skin condition interfering with scalp electrodes or allergy to silver.
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Women will verify not pregnant, and if applicable, have a serum pregnancy test.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Minnesota | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
Investigators
- Principal Investigator: Brian Lundstrom, MD, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 22-008944