EpilepsyPhase 1/2NCT05844696
Electrical Neuromodulation for Focal Epilepsy
A Phase 1/2 study testing Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. in people with Epilepsy, run by National Taiwan University Hospital.
Trial summary
The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1
- Age ≥ 20 years old.
- Focal epilepsy patients having received EEG and brain imaging studies and on standard medication.
- Part 2
- Age ≥ 20 years old.
- Focal epilepsy patients having received EEG and brain imaging studies and on standard medication for at least 1 year.
- Having received part I intervention.
Who cannot join
- Part 1
- Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
- Patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants.
- Patients with allergies to the sponge material used for stimulation.
- Patients with wounds or infections at the site of sponge application.
- Patients with intellectual disabilities, manic episodes (with a score of greater than 12 on the Young Mania Rating Scale), major physiological illnesses (such as stroke, brain tumors, or heart attacks), or pregnant or breastfeeding women.
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- Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
- Part 2
- Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
- Patients who could be considered for single focus resection based on the neurologist/neurosurgeon's judgment. However, patients who clearly refuse resection surgery are not subject to this limitation.
- Patients who experience serious adverse events (SAEs) during the part 1 trial.
- Patients who are unable to undergo magnetic resonance imaging (MRI).
- Patients who are planned to receive hyperthermia therapy or transcranial magnetic stimulation.
- Patients judged by the physician to be unsuitable for the clinical trial due to unstable vital signs or serious internal or external medical conditions.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this research is to use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.
- Conditions
- Epilepsy
- Being tested
- Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.Device
〔Part 1〕Using Soterix MXN-5 HD-tES Model 5005A. Three treatment groups: sham control, continuous tDCS, slow-oscillatory tDCS.
〔Part 2〕Using Medtronic Percept DBS platform. Single group:Neuromodulation.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation | Sham comparator | Not described Receives: Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. |
| continuous tDCS | Experimental | Not described Receives: Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. |
| slow-oscillatory tDCS | Experimental | Not described Receives: Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Any noxious, unintended and undesired effect
Measured: 3 months
Secondary outcomes (1)
The seizure frequency per month
Seizure per month
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844696
- Sponsor's protocol ID
- 202207164DINA
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Neuromodulation for Focal Epilepsy
- ClinicalTrials.gov ID
- NCT05844696
- Acronym / sponsor ID
- 202207164DINA
- Conditions
- Epilepsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 May 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 use electrical neuromodulation on patients with focal epilepsy. The main objective is to assess safety and observe potential therapeutic effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation | Sham comparator | Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. |
| continuous tDCS | Experimental | Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. |
| slow-oscillatory tDCS | Experimental | Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Part 1
- Age ≥ 20 years old.
- Focal epilepsy patients having received EEG and brain imaging studies and on standard medication.
- Part 2
- Age ≥ 20 years old.
Key exclusion criteria (14 listed)
- Part 1
- Patients with secondary and progressive macrostructural abnormalities in the brain, such as brain tumors or infectious lesions. This does not include abnormalities directly related to epilepsy, such as mesial temporal sclerosis or focal dysplasia.
- Patients who are unable to undergo brain electrical stimulation, including those with metal in the brain or implanted stimulators/implants.
- Patients with allergies to the sponge material used for stimulation.
- Patients with wounds or infections at the site of sponge application.
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 |
|---|---|---|
| Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.〔Part 1〕Using Soterix MXN-5 HD-tES Model 5005A. Three treatment groups: sham control, continuous tDCS, slow-oscillatory tDCS. 〔Part 2〕Using Medtronic Percept DBS platform. Single group:Neuromodulation. | Device | Sham stimulation, continuous tDCS, slow-oscillatory tDCS |
Primary outcome
Number of participants with adverse events
Time frame: 3 months
Any noxious, unintended and undesired effect
1 secondary outcome
The seizure frequency per month
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform. in people with Epilepsy, run by National Taiwan University Hospital.
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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tun JAO, M.D., Ph.D. (+886-2-23123456 ext. 265338, tj264@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: 3 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 9 May 2023; AzTrials last refreshed its copy on 4 Nov 2026.