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Electrical Neuromodulation for Focal Epilepsy

Primary Purpose

Epilepsy

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Sham Comparator

    Experimental

    Experimental

    Arm Label

    Sham stimulation

    continuous tDCS

    slow-oscillatory tDCS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of participants with adverse events
    Any noxious, unintended and undesired effect

    Secondary Outcome Measures

    The seizure frequency per month
    Seizure per month

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    May 7, 2023
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05844696
    Brief Title
    Electrical Neuromodulation for Focal Epilepsy
    Official Title
    Electrical Neuromodulation for Focal Epilepsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    May 1, 2025 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epilepsy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sham stimulation
    Arm Type
    Sham Comparator
    Arm Title
    continuous tDCS
    Arm Type
    Experimental
    Arm Title
    slow-oscillatory tDCS
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Soterix MXN-5 HD-tES Model 5005A. Medtronic Percept DBS platform.
    Intervention Description
    〔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.
    Primary Outcome Measure Information:
    Title
    Number of participants with adverse events
    Description
    Any noxious, unintended and undesired effect
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    The seizure frequency per month
    Description
    Seizure per month
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tun JAO, M.D., Ph.D.
    Phone
    +886-2-23123456
    Ext
    265338
    Email
    tj264@ntuh.gov.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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