Electrical Neuromodulation for Focal Epilepsy

National Taiwan University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Epilepsy

Treatments: Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.

Study type: Interventional

Funder types: Other

Identifiers

NCT05844696

202207164DINA

Details and patient eligibility

About

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

Sham stimulation

Sham Comparator group

Treatment:

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

continuous tDCS

Experimental group

Treatment:

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

slow-oscillatory tDCS

Experimental group

Treatment:

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