Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
65 participants
INTERVENTIONAL
2023-05-01
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sham stimulation
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.
continuous tDCS
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.
slow-oscillatory tDCS
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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202207164DINA
Identifier Type: -
Identifier Source: org_study_id
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