Electrical Neuromodulation for Focal Epilepsy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tun JAO, M.D., Ph.D.; Phone Number: 265338 +886-2-23123456; Email: tj264@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham stimulation	Device: 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.
Experimental: continuous tDCS	Device: 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.
Experimental: slow-oscillatory tDCS	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: 202207164DINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No