Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mayo Clinic
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Seizure Count
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS) (Device)
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.
Intervention: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS) (Device)
Outcomes
Primary Outcomes
Seizure Count
Time Frame: 2 months
Number of seizures experienced by subjects as determined by self-reported seizure diary
Secondary Outcomes
- EEG interictal discharge frequency(2 months)
Investigators
Brian N. Lundstrom
Principal Investigator
Mayo Clinic