Focal EpilepsyNCT05673915
Study of Transcranial Direct Current Stimulation to Treat Epilepsy
A study testing ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS) and ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS) in people with Focal Epilepsy and Generalized Onset Epilepsy, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Focal Epilepsy, Generalized Onset Epilepsy, Sleep-related Epileptic Encephalopathy
- What is being tested?
- ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS) and ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
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.
Read the 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.
- Being tested
- ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS), ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS)Device
Stimulation setting 0.1 mA daily for a 2-month period. Each daily treatment will last for approximately 30 minutes.
ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS)Device
Stimulation setting 2.0 mA daily for a 2-month period. A Each daily treatment will last for approximately 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| tDCS Treatment A (Low Amplitude) | Experimental | 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. Receives: Device: ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS) |
| tDCS Treatment B (High Amplitude) | Experimental | 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. Receives: Device: ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Count
Number of seizures experienced by subjects as determined by self-reported seizure diary
Measured: 2 months
Secondary outcomes (1)
EEG interictal discharge frequency
Number of interictal epileptiform discharges observed on electroencephalogram (EEG)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start12 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian N. Lundstrom, Mayo Clinic
- Investigators
- Brian Lundstrom, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673915
- Sponsor's protocol ID
- 22-008944
- Status last verified
- Jan 2026
- First submitted
- 30 Dec 2022
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Transcranial Direct Current Stimulation (tDCS) to Treat Epilepsy
- ClinicalTrials.gov ID
- NCT05673915
- Acronym / sponsor ID
- 22-008944
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS Treatment A (Low Amplitude) | Experimental | Device: 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) | Experimental | Device: 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | tDCS Treatment A (Low Amplitude) |
| 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. | Device | tDCS Treatment B (High Amplitude) |
Primary outcome
Seizure Count
Time frame: 2 months
Number of seizures experienced by subjects as determined by self-reported seizure diary
1 secondary outcome
EEG interictal discharge frequency
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Lundstrom, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActivaDose II 0.1 mA transcranial direct current stimulation (tDCS) and ActivaDose II 2.0 mA transcranial direct current stimulation (tDCS) in people with Focal Epilepsy and Generalized Onset Epilepsy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Precylla Ruiz (507-538-6606, ruiz.precylla@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Count (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.