Study of Transcranial Direct Current Stimulation to Treat Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS), ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS).
- Who it may be relevant to
- Registry conditions: Focal Epilepsy, Generalized Onset Epilepsy, Sleep-related Epileptic Encephalopathy. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Seizure Count [Time frame: 2 months]
Secondary outcome measures (1)
- EEG interictal discharge frequency [Time frame: 2 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05673915 · 22-008944