Electrical Neuromodulation for Focal Epilepsy

Phase 1

Not yet recruiting

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

• Registration Number: NCT05844696
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-04
• Study First Submitted: 2023-04-11
• Study First Submitted QC: 2023-04-25
• Study Start: 2023-05-01
• Study First Posted: 2023-05-06
• Last Update Submitted: 2023-05-07
• Last Update Posted: 2023-05-09
• Primary Completion: 2025-05-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.	-
continuous tDCS	Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.	-
slow-oscillatory tDCS	Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	3 months	Any noxious, unintended and undesired effect

Secondary Outcome Measures

Name	Time	Method
The seizure frequency per month	3 months	Seizure per month