Epilepsy
Conditions
Brief 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.
Interventions
DEVICESoterix 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | 3 months | Any noxious, unintended and undesired effect |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The seizure frequency per month | 3 months | Seizure per month |
Contacts
Primary ContactTun JAO, M.D., Ph.D.
Outcome results
None listed