Electrical Neuromodulation for Focal Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Electrical Neuromodulation for Focal Epilepsy

Conditions
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Epilepsy

Intervention / Treatment
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* Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham stimulation<br> | Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.<br>* 〔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.<br>|
| Experimental: continuous tDCS<br> | Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.<br>* 〔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.<br>|
| Experimental: slow-oscillatory tDCS<br> | Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.<br>* 〔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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Any noxious, unintended and undesired effect | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The seizure frequency per month | Seizure per month | 3 months |